{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "161176",
      "product_res_number": "Z-0696-2018",
      "event_date_initiated": "2017-08-18",
      "event_date_created": "2018-02-23",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-07-07",
      "res_event_number": "79017",
      "product_code": "GCP",
      "k_numbers": [
        "K790071"
      ],
      "product_description": "A20975A \"Working insert, with ramp, one way\" (Lots 13ZW to 172W; A20976A \"Bridge, one way\" (Lots 146W to 172W) and A20977A \"Bridge, two way\" (Lots 146W to 174W)\n\nProduct Usage:\nA20975A: Working insert for endoscopic diagnosis and treatment in urologic applications. A20976A: Bridge for endoscopic diagnosis and treatment in urologic applications. A20977A: Bridge for endoscopic diagnosis and treatment in urologic applications.",
      "code_info": "Model Numbers and Associated  Lot Numbers: A20975A -- 13-ZW to 172W A20976A -- 146W to 172W A20977A -- 146W to 174W",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "address_2": "PO Box 610",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-0610",
      "additional_info_contact": "484-896-5000",
      "reason_for_recall": "Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delamination of the adhesive have also been reported. In one case, a fragment of the adhesive was detected inside a patient's urethra during a procedure and was retrieved without injury to the patient.\n\nThe manufacturer, Olympus Winter & lbe GmbH (\"OWi\") has determined that adhesive can be dislodged during the intended use of the cystoscopy bridge or working insert, e.g., when inserting an instrument through the working channel. As a result, a fragment of the adhesive may fall inside the patient's bladder, urethra or uterus and would need to be retrieved, extending the length of the procedure or requiring additional surgical treatment.\n\nThe adhesive is used to seal gaps inside the working channel of the cystoscopy bridges and working inserts. In 2013, the adhesive used until then was discontinued and had to be replaced. Current investigations revealed that the durability of the new adhesive is insufficient",
      "root_cause_description": "Component change control",
      "action": "On August 18, 2017 an URGENT Medical Device Removal and Corrective Action letter was sent to customers regarding the \"Cystoscopy Bridges and Working Inserts\" instructing customers to review their inventory, quarantine affected product and call customer service at 800-848-9024 to arrange return and replacement.",
      "product_quantity": "8741",
      "distribution_pattern": "US Nationwide Distribution",
      "openfda": {
        "k_number": [
          "K771920",
          "K801247",
          "K771919",
          "K896008",
          "K860103",
          "K896505",
          "K771918",
          "K843683",
          "K954614",
          "K790071",
          "K833859",
          "K862424",
          "K821999"
        ],
        "device_name": "Endoscope, Ac-Powered And Accessories",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "3013031133",
          "3004784537",
          "1000343527",
          "3007960282",
          "8043235",
          "3006680097",
          "3012460907",
          "9614969",
          "3011416394",
          "3011986317",
          "8010257",
          "3007388124",
          "3013247477",
          "9610773",
          "3009217531",
          "8010487"
        ],
        "fei_number": [
          "3013031133",
          "3004784537",
          "1000343527",
          "3007960282",
          "3006680097",
          "3012460907",
          "2981",
          "3011416394",
          "4498",
          "3011986317",
          "1000499348",
          "3007388124",
          "3013247477",
          "4430",
          "3002807798",
          "3009217531"
        ]
      }
    }
  ]
}