MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTIONELECTRODE"PLASMALOOP¿MEDIUM,30°",LOOP,24FR,STANDARD,12°-30°,FORTCRIS; HYSTEROSCOPE

Model Number	WA47506S
Medical Device Problem Codes	Partial Blockage (1065); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and repair.The investigation is still in progress: therefore.The root cause of the reported defect cannot be determined at this time.However.If additional information becomes available.This report will be supplemented accordingly.In general.The customer is required to inspect the device for defects.Check the function of all devices and have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported to olympus that a hf-resectionelectrode was distorted and that there was a catch when passing the sheath.At the time of inspection before use.It was confirmed and replaced with another one, and the planned procedure was completed.There was no patient injury or adverse event reported to olympus.

• Brand Name: HF-RESECTIONELECTRODE"PLASMALOOP¿MEDIUM,30°",LOOP,24FR,STANDARD,12°-30°,FORTCRIS
• Common Device Name: HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16479558
• Report Number: 9610773-2023-00655
• Device Sequence Number: 3136407
• Product Code: JOS
• UDI-Device Identifier: 14042761085042
• UDI-Public: 14042761085042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: WA47506S
• Device Catalogue Number: WA47506S
• Device Lot Number: 1100378839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown