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

Model Number	T3080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Partial thickness (Second Degree) Burn (2694); Swelling/ Edema (4577)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a therapeutic tonsil procedure while using the ultrasonic surgical device, a child received a second-degree mucosal burn on the lips and inner cheeks.The customer stated the problem was thought to be heat from a damaged black sheath that fits over the hook causing swollen lips and cheek burns after the procedure.Upon customer follow-up, it was reported the patient experienced very severe pain requiring local treatment, and the burn was still visible on the lip with esthetical consequences.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
Additional information received: it was reported that no high-frequency output was activated on the generators.The base and the black side of the sheath felt hot to the user.The middle portion of the sheath was in contact with the patient¿s burn.Prolonged contact occurred between the sheath and mucosa; a section of the tonsil, from bottom to top, came into contact with the inside of the cheek.The subject device was used exclusively for tonsillectomy procedures, with an average usage time of 15 minutes per test, until the safety signal was triggered.The output level settings were at 80%.The subject device was isolated at the end of the procedure and was not reused.The user noted that some introducer sheaths appeared damaged at the ring/white seal level and questioned whether this could be due to excessive sterilization cycles or repeated use.It was also noted that the subject device may have come into contact with the lingual blade of the retractor.Additionally, it was reported the age children range from ages 2-4 years.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to fields (h3 and h4) and to provide additional information received through follow up (b3, b5, and d10).The device was evaluated by olympus, and it was found that the insulation coating at the insertion section had torn.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, it is likely that the reported event "the lips and inner cheeks are burnt" occurred due to the following mechanisms: 1.Prolonged output with the combined use of the t3080 led to a rise in temperature in its insertion section, resulting in high temperatures.2.The heated insertion section came into contact with the inner surfaces of the patient¿s lips and cheek.Additionally, it is likely that the reported event "breaks (scratches or cracks or deforms) in the insulated part of the shaft" occurred due to the following mechanisms: 1.Contact with a hard object, such as metal, near the proximal end of the insertion section resulted in the formation of a crack in the insulation coating.2.Because autoclave sterilization was performed while a crack existed in the insulation coating, heat was applied to the affected area, leading to shrinkage of the insulation coating originating from the crack.3.Due to the shrinkage of the insulation coating, the tear progressed, resulting in exposure of the insertion pipe.4.As the autoclave sterilization was further performed with the insertion pipe exposed, the insulation coating tore circumferentially.The event can be detected/prevented by following the instructions for use which state: "before activating the output, be sure that the probe comes into contact with the target tissue, and confirm that there is sufficient clearance between the tip probe and non-target tissue." "whenever possible, avoid touching the insertion section of the sheath in contact with tissue.If ultrasonic output is activated for a long time, the surface temperature of the insertion section rises and it could cause burns to tissue with which it comes in contact." "the probe becomes hot due to extended ultrasonic output.Do not let it come in contact with tissues other than the target tissue because it may burn the tissue." "since the temperature of the tip probe rises with continued use of the instrument, ensure that the instrument does not come in contact with non-target tissue.Otherwise, a burn may occur." "when extracting the instrument from the trocar tube, do not apply excessive force, as the hook may be caught on the rim of the trocar tube.In this case, try to extract it by rotating it slowly.Attempting to extract the instrument by excessive force may cause damage and/or make it impossible to remove the instrument from the trocar tube (when using the long hook)." olympus will continue to monitor field performance for this device.

• Brand Name: SONOSURG SHORT HOOK 5MM O.D.
• 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: 20005974
• Report Number: 9614641-2024-01663
• Device Sequence Number: 4374582
• Product Code: LFL
• UDI-Device Identifier: 04953170152375
• UDI-Public: 04953170152375
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: T3080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2024
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DAVIS BOYLE BIPOLAR FORCEPS.; DAVIS BOYLE LINGUAL BLADE; SONOSURG-G2 SET GENERATOR (SN (B)(6).; SONOSURG-T2H TRANSDUCER (SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown