MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, ALLIGATOR TYPE; HI-Q HAND INSTRUMENTS- UROLOGY

Model Number	A64070A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation therefore the complaint could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the following led to the malfunction: the cause is very likely improper handling/excessive force, in combination with wear and tear.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the jaws alligator type hiq had the jaws fitting gap worn out as it was too wide.The issue occurred during preparation for use.There were no reports of patient harm.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, ALLIGATOR TYPE
• Common Device Name: HI-Q HAND INSTRUMENTS- UROLOGY
• 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: 17999718
• Report Number: 9610773-2023-03057
• Device Sequence Number: 15142063
• Product Code: HET
• UDI-Device Identifier: 04042761010115
• UDI-Public: 04042761010115
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K944201
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

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: A64070A
• Device Lot Number: 133W-0006
• 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: 10/03/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• 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