MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONOSURG CURVED SCISSORS,HF,INLINE GRIP,5MM X 34CM; ULTRASONIC SURGICAL DEVICE

Model Number T3915

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the sonosurg curved scissors had exposed metal at the base of the insulation sheath.The issue was found during an unidentified procedure that was completed with a similar device.The device was returned for evaluation.During the device evaluation, there were signs of device activation without grasping tissue that resulted in the tissue pad peeling which constitutes a reportable malfunction.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

E1 establishment name: (b)(6) hospital.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information including further information provided by customer and the legal manufacturer's final investigation.According to the customer, the device was cleaned with neutral detergent, rinsed and autoclave sterilized.The autoclave was set to 132° 10 minutes, a high temperature dryer was used (manufacturer: asuka medical) temperature settings: 70-80°.It was unknown the number of times the device had been used.The issue was observed during the sterilization process when checking the insulation using sakura seiki diateg professional insulation tester.A neutral detergent was used (chemical name unknown).The flow of reprocessing includes wash, rinse, high temperature dryer, autoclave sterilization and insulation check.There were no recent changes.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 possible that the application of excessive heat may have shortened the insulation tube exposing the metal.However, the exact cause of the reported event could not be identified.During the evaluation, signs were noted of the grasping section being closed without grasping anything in between the grasping section and the probe when the ultrasonic output was repeatedly activated resulting in the tissue pad peeling.The issue can be detected/prevented by following the instructions provided in: t3915 instruction manual provides the following: warning - if the insulation on the insertion section of this instrument is scratched, damaged, peeled off, dislocated or loose, current leakage from the damaged part may cause operator or patient burns.If the insulation is damaged, stop using the instrument and contact olympus.¿ steam sterilization (autoclaving) when steam sterilizing, follow the hospital¿s protocol and the sterilization equipment manufacturer¿s instructions.Warning - do not activate output when closing the instrument and nothing is grasped between the grasping section and the probe, or when it is not possible to confirm that the tissue being grasped has been completely resected.Otherwise, abnormal heat generated by friction between the grasping section and the probe may damage the grasping section or cause it to detach or premature wear in the grasping surface.Olympus will continue to monitor field performance for this device.

• Brand Name: SONOSURG CURVED SCISSORS,HF,INLINE GRIP,5MM X 34CM
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18502760
• MDR Text Key: 333213398
• Report Number: 9614641-2024-00077
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170235689
• UDI-Public: 04953170235689
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T3915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2023
• 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