MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE; HYSTEROSCOPE

Model Number A22205D

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

Brand name hf-resection electrode, loop, 24 fr., 0.2 wire, 30°, sterile, single use, 12 pcs.Pma/510k: k790071/ k903323/ k951863/ k954488.Related patient identifiers: patient identifier (b)(6) addresses event date (b)(6) 2023 and patient identifier (b)(6) addresses event (b)(6) 2023 the device was returned to olympus for evaluation.A visual inspection confirmed that the loop was missing from the forks on the distal; the distal end was observed under a microscope, there is indication of burnt marks as well as melted insulation on the forks; the forks are slightly bent and deformed; the shaft as well as the proximal end have no indications of bends, kinks, or other signs of damages, and the stabilizing tube appears to have no deformities.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

An olympus representative reported, that during a therapeutic procedure for a trans-urethral resection of prostate, the wire on the distal end was frayed.The procedure was completed using a similar device.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the cause of the reported issue is due to wear and tear.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-RESECTION ELECTRODE
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16506138
• MDR Text Key: 311566721
• Report Number: 9610773-2023-00687
• Device Sequence Number: 1
• Product Code: GCP
• UDI-Device Identifier: 14042761036716
• UDI-Public: 14042761036716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22205D
• Device Catalogue Number: A22205D
• Device Lot Number: 1000098399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1