MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-ELECTRODE, HOOK, 5 X 330 MM; OES LAPAROSCOPY SYSTEM

Model Number	A6282
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The device was evaluated and repaired onsite at local service center (third party distributor).A review of the device history record confirmed the device had no non-conformities or deviations regarding the event.It has been five years since the subject device was manufactured.Based on the results of the investigation, the likely cause of the event is improper handling of the customer during reprocessing or use (e.G., impact, drop, fall).Olympus will continue to monitor the field performance of this device.Supplemental report(s) will be submitted should any relevant new information is available and or received.
Event or Problem Description
The customer reported that the insulation of the hook was damaged on a hf-electrode, hook, 5 x 330 mm.The event occurred during preparation for use.The therapeutic procedure (laparoscopic cholecystectomy) was completed with the same device.There was no procedural delay, or no patient harm associated with the event.

• Brand Name: HF-ELECTRODE, HOOK, 5 X 330 MM
• Common Device Name: OES LAPAROSCOPY SYSTEM
• 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: 17547029
• Report Number: 9610773-2023-02234
• Device Sequence Number: 6657580
• Product Code: GCJ
• UDI-Device Identifier: 04042761028868
• UDI-Public: 04042761028868
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K923982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2023

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: A6282
• Device Lot Number: 808637
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2018
• 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