MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONOSURG SCISSORS 5 MM O.D., HF SERIES; ULTRASONIC SURGICAL DEVICE

Model Number	T3155
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the sonosurg scissors 5 mm o.D., hf series tissue pad of the scissors had broken off.There was no patient harm associated with the event.The device was evaluated, and it was found that there was falling of grasping part.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was not confirmed.In addition to the finding of falling of grasping part due to excessive load.There are no additional findings.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Updated fields: h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 4 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the grasping section was closed without grasping anything between the grasping section and the distal end of the probe.This resulted in repeated ultrasonic output causing breakage.The event can be prevented by following the instructions for use which state: if the instrument is visibly damaged, does not function as expected or is found to have other irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the instrument; contact olympus.Some problems that appear to be malfunctions may be correctable by referring to section 8.1, ¿troubleshooting guide¿.If the problem cannot be resolved by the described remedial action, stop using the instrument and send it to olympus for repair.Olympus will continue to monitor field performance for this device.

• Brand Name: SONOSURG SCISSORS 5 MM O.D., HF SERIES
• 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: 17654176
• Report Number: 9614641-2023-01261
• Device Sequence Number: 7269314
• Product Code: LFL
• UDI-Device Identifier: 04953170208737
• UDI-Public: 04953170208737
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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: T3155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2018
• 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