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

Model Number WA64700A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

The customer contacted the olympus technical assistance center (tac), to report the distal jaw non articulating jaw broke off and fell into the patient during a robotics laparoscopic proctectomy.The customer retrieved the piece that broke off and completed the procedure.No patient injury was reported.

Manufacturer Narrative

In speaking with olympus technical assistance center (tac), the customer declined trouble shooting.The device has not been returned to olympus for evaluation.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

Updated fields: d8, e4, h4, h6, h10 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, the root cause could not be determined as the device was not returned for evaluation.Although the device was not returned, based on the customer's description, it is likely the reported event occurred due wear and tear.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, NEEDLE HOLDER, STRAIGHT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, de 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: 16074477
• MDR Text Key: 308534373
• Report Number: 9610773-2022-00797
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA64700A
• Device Catalogue Number: WA64700A
• Device Lot Number: 111W0002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1