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

Model Number	T3905
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed, the ultrasound output abnormality light came on when outputting ultrasound, and the device stopped working.The device evaluation found that the gripping surface was worn and partially peeled off.Additional findings include the following: a crack had formed at a position 14mm from the tip of the probe, there were scratched around the crack in the probe.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The olympus representative (on behalf of the customer) reported to olympus, the sonosurg curved scissors, hf, pistol grip, 5mm x 34cm was used for the second time after delivery, the ultrasound output abnormality light came on when outputting ultrasound, and it stopped working.The issue was found during an unspecified procedure, which was completed with a similar device.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the gripping surface was worn and partially peeled off.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
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, a likely factor of the event might be the following: 1.The ultrasonic output was activated while the probe was in contact with the hard objects such as clips or forceps, or the probe was scraped by using a sharp object, such as surgical tools to remove foreign substance adhesion.As a result, the probe had scratches.2.A force might have been applied to the probe due to continuous use of the probe with scratches.Therefore, the probe crack at the scratched area.3.Ultrasonic output warning lamp lights up and output stops.A definitive root cause cannot be identified.The grasping section might have been closed without grasping anything in between the grasping section and the distal end of the probe when the ultrasonic output was repeatedly activated, or it was not possible to confirm whether the tissue was completely resected when the ultrasonic output was repeatedly activated.These reasons might have been contributed to the worn out and peeling of the grasping surface.The content of the instruction manual was confirmed.The instruction manual contains the necessary information to handle the device as follows: 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.Do not activate ultrasonic output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such a metal clips or other instruments (e.G., metal clips, uterine manipulators, or other instruments).Do not apply only the probe to the tissue with strong force or do not twist or pull the probe up while grasping the tissue.Otherwise, the probe may become too hot and break before the generator gives a warning lamp/sound.When the probe is contaminated by carbonized the tissue, use a piece of moistened, soft gauze to remove the tissue.Do not attempt to scrape it with a sharp object such as a scalpel.Otherwise, the probe may be scratched or break and detach into the body cavity during ultrasonic output.Olympus will continue to monitor field performance for this device.

• Brand Name: SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM
• Common Device Name: 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: 17765972
• Report Number: 9614641-2023-01328
• Device Sequence Number: 20626138
• Product Code: LFL
• UDI-Device Identifier: 04953170235665
• UDI-Public: 04953170235665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: T3905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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