MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT OPEN FINE JAW; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0009OF
Medical Device Problem Codes	Fracture (1260); Peeled/Delaminated (1454); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported to olympus, a physician was using the thunderbeat open fine claw 9 centimeter handpiece consumables and encountered some problems.The device started to alarm, and the surgeon realized the tip of the thunderbeat had dislodged.When the second thunderbeat also experienced this same event; the therapeutic haemorrhoidectomy was completed using a replacement device (harmonic).After the first event, the scrub nurse put the dislodged tip back to see if there was any missing part.It was confirmed that nothing went into the patient¿s body from either thunderbeats.There was no report of patient harm associated with this device.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of broken probe was confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, to correct h10 on the initial, and to add additional reportable malfunction (peeling of the tissue pad) to h6/h10.Correction to h10: the customer's allegation of a broken probe was not confirmed.The defects identified were peeling and tearing of the tissue pad.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, the root cause of the peeling tissue pad could not be conclusively determined.It is likely the defect occurred due to one of the following: 1)during the output activation in seal & cut mode, nothing was grasped in between the grasping section and the distal end of the probe (this includes after tissue resection).Therefore, the tissue pad was worn out.2) due to friction between the grasping section and the distal end of the probe, abnormal heat was generated.This might have caused the tissue pad to partially peel off and torn.The event can be detected/prevented by following the instructions for use which state: "do not activate output in seal & cut mode while the grasping section is closed without contacting tissue or vessel or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.When cutting and vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm that they are transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation".Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT OPEN FINE JAW
• 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: 17783941
• Report Number: 9614641-2023-01350
• Device Sequence Number: 14838879
• Product Code: GEI
• UDI-Device Identifier: 14953170343343
• UDI-Public: 04953170343346
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: TB-0009OF
• Device Lot Number: 23K24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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
• Patient Sex: Unknown