MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH ELECTRODE; ENDOSCOPE, AC-POWERED AND ACCESSORIES

Model Number A22251C

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2023

Event Type  Injury  

Event Description

A company representative, on behalf of the customer, reported to olympus that during a transurethral resection of the prostate, the monopolar rollerball of the hf-resection electrode broke off in patient.Despite multiple attempts to obtain additional information regarding the device and event, none was obtained.

Manufacturer Narrative

D1, full name: hf-resection electrode, roller, 24-28 fr., 12° and 30°, sterile, single use, 12 pcs.This report was submitted by the importer under the importer's report number: 2429304-2023-00376 the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: ELECTRODE
• Type of Device: ENDOSCOPE, AC-POWERED AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18247726
• MDR Text Key: 329497404
• Report Number: 9610773-2023-03460
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036815
• UDI-Public: 14042761036815
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/01/2023

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: A22251C
• Device Lot Number: 1000085722
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male