MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Jaws "HiQ+", 5 x 330 mm, needle holder, curved; Suturing needle holder, reusable

Model Number	WA64710A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reusable suturing needle holder was delivered with a broken tip.The malfunction was identified during installation.There were no reports of patient involvement.
Additional Manufacturer Narrative
Investigation is in progress.A supplemental report will be submitted upon investigation completion.

• Brand Name: Jaws "HiQ+", 5 x 330 mm, needle holder, curved
• Common Device Name: Suturing needle holder, 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: 50483684
• Report Number: 9610773-2026-05840
• Device Sequence Number: 10233740
• Product Code: GCJ
• UDI-Device Identifier: 04042761031073
• UDI-Public: 04042761031073
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K923982/ K91
• 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: WA64710A
• Device Lot Number: 26501
• 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