MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR.; ENDOSCOPE SHEATH, REUSABLE

Model Number A22041A

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2022

Event Type  Injury  

Event Description

Olympus corporation of the americas (oca) received a medwatch 5114040, which reported that a foreign body was retrieved from the anterior portion of the prostate fossa of the patient during a cystoscopy with bladder biopsy.The foreign body was confirmed to be consistent with the beak of a resectoscope.The patient had a prior cystoscopy with transurethral resection of the prostate and bladder tumor, and it was believed that the beak tip broke off of the inner sheath of the resectoscope that was used during that time.There were no patient complaints, and the foreign body was an incidental finding during the follow-up procedure.There was no further harm or user injury reported due to the event.

• Brand Name: RESECTION SHEATH, 24 FR.
• Type of Device: ENDOSCOPE SHEATH, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 16186019
• MDR Text Key: 307511445
• Report Number: 2429304-2023-00008
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04042761020961
• UDI-Public: 04042761020961
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2022,01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22041A
• Device Catalogue Number: A22041A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White