MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM; ULTRASONIC SURGICAL DEVICE

Model Number T3905

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available a follow up medical device report will be supplemented accordingly.

Event Description

Olympus (ot) was informed by the user facility that the high frequency sonosurg curved scissors was used in a therapeutic laparascopic appendectomy procedure, "the tip probe was damaged and dropped into the body.The dropped pieces were recovered and replaced with another one of the same product, and the procedure was continued and completed".No patient health hazards was reported to olympus.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since the serial number of the device is unknown, as a result of checking the dhr for the past 6 months from the date of occurrence, there were no abnormalities in the following items related to the event pointed out.Based on the results of the investigation, it is likely that a load has been applied to the probe, or there was contact with other devices.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "¿ when outputting ultrasonic waves, do not output while twisting the insertion part or turning the rotary knob while grasping hard or thick tissue.The load on the probe may increase, leading to breakage or dropout, or the probe may interfere with internal components and damage the probe, leading to breakage or dropout.¿ when outputting ultrasonic waves while pressing only the tip of the probe strongly against the tissue, the probe may interfere with internal parts, causing scratches on the probe and causing breakage or dropping.¿ this product is intended for soft tissues.Do not output ultrasound while holding a hard tissue such as bone or calcified tissue with the tip of the probe, or a metal clip or other surgical device (such as a uterine manipulator).The probe may become hot and break before the ultrasonic output warning indicator lights up or the warning sound is heard.¿ remove stains such as scorching on the tip of the probe with a soft material such as gauze.If you try to scrape it off with a hard object such as a scalpel blade, the tip of the probe may be scratched, and the probe may break during ultrasonic output and fall into the body cavity." olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13690376
• MDR Text Key: 296799213
• Report Number: 8010047-2022-04050
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170235665
• UDI-Public: 4953170235665
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T3905
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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