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

Model Number	WA64150A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus that during an unspecified therapeutic procedure using the jaws "hiq+", 5 x 330 mm, grasping forceps, croceolmi, it became impossible to grasp."abnormal noise" was reported.The shaft of the unit separated from the moving part of the jaw, and did not interlock with the handle operation.It was stated that "fracture surface" was not visible and deformation of the combined sheaths was confirmed.The procedure was completed by replacing the equipment with similar equipment.It was also stated that the at the time of the report, the hospital could not confirm the parts had not been retained in the patient, and it was being treated as if the devices had fallen into a body cavity.Additional information was requested multiple times, but was not received.This event involved 3 devices.Patient identifier (b)(6) is for the jaws "hiq+", 5 x 330 mm, grasping forceps, croceolmi.Patient identifier (b)(6) is for the shaft "hiq+", 5 x 330 mm.Patient identifier (b)(6) is for the handle "hiq+", ergo s, unipolar.
Additional Manufacturer Narrative
Full facility name: (b)(6) hospital the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The complete evaluation results are as followed: the pull rod is broken or cracked at the interface to the jaw axis.In addition, the pull rod was found severely deformed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the suggested event occurred due to the broken pull rod which can be attributed to application of excessive force.It is possible that a damage to the jaws was caused during reprocessing.This type of breakage indicates a massive impact by force, which can only occur when the jaws are wide open.However, the root cause of the suggested event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16911524
• Report Number: 9610773-2023-01287
• Device Sequence Number: 15011463
• Product Code: HET
• UDI-Device Identifier: 04042761068970
• UDI-Public: 04042761068970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA64150A
• Device Catalogue Number: WA64150A
• Device Lot Number: 21Z02-014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE "HIQ+", ERGO S, UNIPOLAR ¿ LOT 21702-0007.; SHAFT "HIQ+", 5 X 330 MM ¿ LOT 21814-0023.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown