MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 35 CM, PISTOL GRIP; INSTRUMENT

Model Number	SB-0535PC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy, metal shards were coming off the base of the tip of the suspect device prior to the jaws being opened.A metal shard was seen on the patient¿s gallbladder and retrieved with a grasper.The procedure was completed with no patient harm reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.The device was returned to olympus for inspection, and the reported failure was confirmed due to a tiny piece of the metal chipped on the top of one jaw.However, the device passed functional testing in accordance with the instruction manual.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: inherent risk of device.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information was obtained from the customer.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00053.This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.Updated fields: h2 and h6.Corrections to b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, there is no evidence the patient suffered any serious injury or adverse effects from the prolonged procedure.Olympus made multiple attempts to receive more information from the customer without success.Thus, correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported, and other findings would not cause or contribute to a death or a serious injury if it were to recur.The device was returned to olympus for inspection and the customer's complaint was confirmed.Based on the investigation, the definitive root cause could not be determined.The most probable cause of the complaint is: cause traced to component failure: the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Olympus will continue to monitor field performance for this device.

• Brand Name: SONICBEAT 5 MM, 35 CM, PISTOL GRIP
• Common Device Name: INSTRUMENT
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22736635
• Report Number: 9614641-2025-01338
• Device Sequence Number: 9120814
• Product Code: LFL
• UDI-Device Identifier: 04953170465024
• UDI-Public: 04953170465024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: SB-0535PC
• Device Lot Number: 51K16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ETHICON TROCAR XCEL ENDOPATH BLADELESS 5/100 MM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown