MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Jaws "HiQ+", bipolar, 5 x 330 mm, dissection forceps, Maryland; Rigid endoscopic tissue manipulation forceps, reusable

Model Number	WA64360C
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reusable rigid endoscopic tissue manipulation forceps exhibited the tip is coming off.The malfunction was identified during reprocessing.There were no reports of patient inolvement.
Additional Manufacturer Narrative
Investigation is in progress.A supplemental report will be submitted upon investigation completion.

• Brand Name: Jaws "HiQ+", bipolar, 5 x 330 mm, dissection forceps, Maryland
• 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 ; +1(508)207-7661
• MDR Report Key: 50477209
• Report Number: 9610773-2026-05822
• Device Sequence Number: 10396008
• Product Code: HET
• UDI-Device Identifier: 04042761068611
• UDI-Public: 04042761068611
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K944200/ K94
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: WA64360C
• Device Lot Number: 26204-0007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown