MAUDE Adverse Event Report: OLYMPUS AMERICA, INC SINGLE USE DISTAL COVER; ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE

Model Number MAJ-2315

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/05/2022

Event Type  Injury  

Event Description

Mw u/f report 45-0684-2022-2: the customer reported at the end of a therapeutic ercp, while removing the endoscope from the patient, the distal cover fell inside the patient.The surgeon made multiple attempts to retrieve the distal cover from inside the patient.Inserted a different endoscope to try and locate the distal cover multiple times but was unable to locate it.The intended procedure was successfully completed using the same devices.There was approximately a five (5) minute delay in the procedure due to the malfunction.The patient was discharged and it is unknown if the distal cover was passed out of the patient.The endoscope and distal cover were inspected prior to use and no issues were identified.No anti-fog agents or chemicals were used.The facility confirmed the distal cover was securely attached to the endoscope before use and no damages were identified on the distal cover.Three (3) events reported by facility as follows: for event 1 of 3, see (b)(6).For event 2 of 3, see (b)(6).For event 3 of 3, see (b)(6).This is event 3 of 3 from the facility and includes 2 reports: (b)(6): maj-2315.H1y30.(b)(6): tjf-q190v, 2124607.

• Brand Name: SINGLE USE DISTAL COVER
• Type of Device: ENDOSCOPE PATIENT PROTECTION CAP, SINGLE-USE
• Manufacturer (Section D): OLYMPUS AMERICA, INC; 3500 corporate parkway; center valley PA 18034 0610
• MDR Report Key: 15205823
• MDR Text Key: 297687112
• Report Number: 2429304-2022-00021
• Device Sequence Number: 1
• Product Code: NWB
• UDI-Device Identifier: 04953170403019
• UDI-Public: 04953170403019
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2022,08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-2315
• Device Lot Number: H1Y30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TJF-Q190V, 2124607
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 157 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American