MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HANDLE "HIQ+", ERGO S, UNIPOLAR; HI-Q HAND INSTRUMENTS- UROLOGY

Model Number	A60201A
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1.Full facility name: (b)(6) university hospital the device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 reported issue can be attributed to the combination article wa64150a jaws "hiq+", 5 x 330 mm, grasping forceps, croceolmi, lot#: 21z02-014 addressed within complaint # (b)(4).The returned grasping forceps showed broken or cracked pull rod at the interface to the jaw axis and severe deformation.This type of damage was attributed to excessive force, which can only occur when the jaws are wide open.However, the subject device was not returned and the root cause of the failure could not be determined.However, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: HANDLE "HIQ+", ERGO S, UNIPOLAR
• 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: 16911611
• Report Number: 9610773-2023-01288
• Device Sequence Number: 17646633
• Product Code: HET
• UDI-Device Identifier: 04042761009799
• UDI-Public: 04042761009799
• 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): 09/11/2023

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: A60201A
• Device Catalogue Number: A60201A
• Device Lot Number: 21702-0007
• Was Device Available for Evaluation?: No
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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: JAWS "HIQ+",5X330 MM,GRASP FORCEPS-LOT 21Z02-014.; SHAFT "HIQ+", 5 X 330 MM ¿ LOT 21814-0023.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown