MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR; RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, REUSABLE

Model Number	WA69410M
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the investigation, it is likely due to wear and tear and due to excessive force led to the malfunction.A definitive root cause could not be identified.Before use, it is the customer's responsibility to inspect his equipment for damage and other irregularities and, if necessary, to discard it.Especially in the case of damaged insulation or a badly worn insulating body in the proximal area of the mouth, unintentional, untargeted coagulation and/or severe burns of the patient can occur.Therefore, mouth inserts must be visually inspected before use, e.G.For the following damage and discarded if necessary.Deformations of any kind such as dents, cracks, deep scratches, defects in and on the insulation, as well as on dirt, corrosion and visibility of the marking.See also instructions for use chapter 4.2.2 specific inspection.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed during the device inspection, that the bipolar instrument exhibited the insulating body located between the halves of the mouth was worn.There were no reports of patient involvement.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, JOHANN, BIPOLAR
• Common Device Name: RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, REUSABLE
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20391268
• Report Number: 9610773-2024-02459
• Device Sequence Number: 15094717
• Product Code: GEI
• UDI-Device Identifier: 04042761079976
• UDI-Public: 04042761079976
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K140624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2024

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: Other
• Device Model Number: WA69410M
• Device Lot Number: 23101-0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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