MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONOSURG CURVED SCISSORS,HF,INLINE GRIP,5MM X 19CM; ULTRASONIC SURGICAL DEVICE

Model Number	T3925
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported after a distal pancreatectomy using sonosurg scissors, burns were found on the patient that were close to the size of the sonosurg scissors.Intraoperatively, the sonosurg scissors had been placed on the patient.The exact location and severity of the burn was not provided.It is unknown if the patient required treatment/intention for the burn.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Additional Manufacturer Narrative
This report is being updated to provide investigation findings.New information is reported in h6 and h10.Physical evaluation: the subject device was not returned to olympus; therefore, the reported phenomenon or condition of the device could not be confirmed.Device history record (dhr) review: since the serial number of the subject was unknown, the dhr for the past six months prior to the date of occurrence was inspected.No abnormalities were detected in the dhr for the following items which related to the reported phenomenon.- process inspection.- quality inspection sheet.- non-conforming product sheet.The instructions for use (ifu) provides the following information to the user related to the reported event: ¿ the probe becomes hot due to extended ultrasonic output.Do not let it come in contact with tissues other than the target tissue, as it may burn the tissue.After the instrument is withdrawn from patient, do not leave it on certain parts of patient body such as abdominal area or chest.Also, do not allow medical personnel to come in contact with the instrument.It may cause burns on the surgical drape or gown as well as on the personnel.Burns may result even through the surgical drape or gown.Conclusion summary: complaint information shows that it is not a device issue, it is possible that the device became hot immediately right after output activation.This device might have touched the lower abdomen of the patient, causing the reported phenomenon.
Event or Problem Description
Update: additional information provided by the customer: the sonosurg was placed immediately after performing output in the abdominal cavity.(several times).We do not have information such as depth of burn.
Additional Manufacturer Narrative
This report is being updated to provide additional information reported by the customer.New information is reported in b5.

• Brand Name: SONOSURG CURVED SCISSORS,HF,INLINE GRIP,5MM X 19CM
• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15429446
• Report Number: 9614641-2022-00319
• Device Sequence Number: 7529627
• Product Code: LFL
• UDI-Device Identifier: 04953170235702
• UDI-Public: 04953170235702
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/28/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: T3925
• Was Device Available for Evaluation?: No
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 10/06/2022; 11/28/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 11/01/2022; 11/28/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female