MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI

Model Number	WA64150A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center.The repair inspection confirmed the customer¿s reported issue, the jaws do not open due to a defective pull rod.The transmission rod near the jaws is broken, and the distal pulling wire is clearly deformed.This damage indicates that excessive force is very likely exerted on the item when the jaws are open.A manufacturing and quality control review was performed for the affected lot number without showing any non-conformities or deviations regarding the described issue.Based on the investigation results, the legal manufacturer determined the cause for this issue is likely due to improper handling (excessive force) by the user.Olympus will continue to monitor the occurrence rate of the reported phenomenon related to the device.
Event or Problem Description
Olympus (oekg) was informed by the head nurse at the user facility that the customer hiq+ croceolmi grasping forceps ¿jaws aren¿t responsive at all.¿ the customer reported problem occurred during a cholecystectomy.The broken area is between the jaws and it is completely loose.There was only a couple of minutes delay, and the procedure was completed with a replacement device.No death or injury and no harm to patient.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI
• Common Device Name: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16238918
• Report Number: 9610773-2023-00339
• Device Sequence Number: 17755719
• Product Code: HET
• UDI-Device Identifier: 04042761068970
• UDI-Public: 04042761068970
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: WA64150A
• Device Catalogue Number: WA64150A
• Device Lot Number: 22301-015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• 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: 12/28/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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
• Patient Sex: Unknown