MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-CABLE, MONOPOLAR; LAPAROSCOPE

Model Number	A0393
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the end of a diagnostic hysteroscopy procedure, increasing the core output setting from 30 to 70 caused sparks to fly, cutting off part of the insertion port from the high frequency-cable.The procedure was then completed with another device, and no patient harm was reported.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected data field: g2 (remove healthcare professional) a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, it is like that the reported event was caused by during handling with possible application of mechanical force, stress, bending and pulling.Olympus will continue to monitor field performance for this device.

• Brand Name: HF-CABLE, MONOPOLAR
• Common Device Name: LAPAROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19343179
• Report Number: 9610773-2024-01268
• Device Sequence Number: 7130933
• Product Code: GCJ
• UDI-Device Identifier: 04042761001656
• UDI-Public: 04042761001656
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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: A0393
• Device Lot Number: 824117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown