MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP

Model Number A22202C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to olympus for evaluation.Therefore, the cause of the reported event is unknown.However, the investigation is ongoing.If additional information becomes available this report will be supplemented accordingly.

Event Description

Olympus received a medwatch ((b)(4)) from the fda via mail.The medwatch states that "during the procedure the surgeon stated the resectoscope loop broke off in the patient." the date of event was in(b)(6) 2020.No patient injury was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the customer as part of the investigation, olympus followed up with the user facility to obtain additional information.The risk manager at the user facility reported that the event occurred on (b)(6) 2020.No additional information was provided.The legal manufacturer performed the device history records for this device and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The reported issue can most likely be attributed to wear and tear.The loop at the distal end wears out during use and may burn or melt if broken.Olympus will continue to monitor complaints for this device.

• Brand Name: HF-RESECTION ELECTRODE, LOOP
• Type of Device: HF-RESECTION ELECTRODE, LOOP
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 10719049
• MDR Text Key: 232791365
• Report Number: 9610773-2020-00241
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036662
• UDI-Public: 14042761036662
• Combination Product (y/n): N
• PMA/PMN Number: K954488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: A22202C
• Device Catalogue Number: A22202C
• Device Lot Number: 1000037291
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR