MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT; NEEDLE HOLDER, REUSABLE

Model Number	WA64700A
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that there was bending of the tip.The issue was found upon installation.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information and results of the final investigation.Please see updates to d9, h2, h6, and h11.The device was not returned to olympus for inspection; therefore, the reportable malfunction was not confirmed.Based on the results of the investigation, the root cause of the reportable malfunction could not be determined as there was no product returned.The event can be detected/prevented by following the instructions for use which state: chapter5.1 assembly caution risk of damaging the instrument make sure to turn the jaws insert until it stops during assembly of the needle holder as described above.If the jaws insert is not securely attached to the handle, the jaws insert will be overstressed during use and may be damaged should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
There is no new information provided by the customer.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT
• Common Device Name: 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 ; 5082077661
• MDR Report Key: 21446842
• Report Number: 9610773-2025-01280
• Device Sequence Number: 7196213
• Product Code: GCJ
• UDI-Device Identifier: 04042761031097
• UDI-Public: 04042761031097
• Combination Product (Y/N): N
• PMA/510(K) Number: K923982/ K91
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: WA64700A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown