MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TORS BLADE "FK-WO TORS", ACC. TO WEINSTEIN-O'MALLEY, S, RIGHT; RETRACTOR, ENT

Model Number	WT645031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The olympus representative reported on behalf of the customer that during the transoral robotic resection of a tumor on the base the tongue, the fk-wo tors retractor snapped while in the patient's mouth.The gag had been placed in the patient¿s mouth, and the blade snapped in half prior to the robot being docked and before the resection of the tongue base tumor started.The procedure was delayed about ten minutes as the device was replaced with a second fk retractor and the patient's anesthesia was extended the same amount of time.The tumor was successfully resected with a different fk retractor and there was no extended hospital stay.On inspection there was no damage to the patient's teeth, however post-operatively the patient complained of having pain.Additional treatment consisted of several reviews by the dentist and it was determined the patient has nerve root injury to the tooth.The device was inspected before use and there were no other devices involved.
Additional Manufacturer Narrative
The device has been returned for analysis and is pending evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer¿s reported device defect was confirmed.The tors blade was broken in two along the laser weld.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, the reported defect was likely caused by improper handling, more specifically from excessive force by the user.Olympus will continue to monitor field performance for this device.

• Brand Name: TORS BLADE "FK-WO TORS", ACC. TO WEINSTEIN-O'MALLEY, S, RIGHT
• Common Device Name: RETRACTOR, ENT
• 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: 17438337
• Report Number: 9610773-2023-02091
• Device Sequence Number: 15688907
• Product Code: KAL
• UDI-Device Identifier: 04042761083287
• UDI-Public: 04042761083287
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: WT645031
• Device Lot Number: 05-12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2012
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male