MAUDE Adverse Event Report: UNKNOWN UNKNOWN THUNDERBEAT HANDPEICE; ULTRASONIC SURGICAL DEVICE

Model Number UNKNOWN

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2951238-2021-00461.

Event Description

The customer reported during a therapeutic living donor liver recipient procedure, the patient received a 2nd degree burn by the subject device after it touched the patient's leg.The customer reported they smelled burned flesh and did not hear an activation noise because the volume was turned down.The burn was noticed when the drapes were removed at the end of the case.The burn was treated with a silver product.The customer stated they will continue to evaluate the patient's burn and if it does not heal the patient will need a skin graft.The customer reported they were not aware of any olympus malfunction.The intended procedure was completed with the same subject device.The olympus generator settings during the procedure are unknown.It is unknown if the device was inspected prior to the procedure.It is unknown if there was a delay in the procedure or if any other devices were involved in the event.

Manufacturer Narrative

Correction: h8.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the applicable correction.New information was added to the following fields: d8, h6, h10.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.A definitive root cause was not identified.However based on the past investigation results, the legal manufacturer determined the device likely became hot immediately right after output activation.This device might have touched the drape laid on the patient, causing the reported phenomenon.The event can be detected/prevented by following the instructions for use which state: to seal adjacent tissue, overlap the edge of the existing seal.The second seal should be distal to the first seal to increase seal margin.Otherwise, incomplete sealing may cause bleeding and/or the existing seal may be opened.The grasping section and probe tip become hot due to extended ultrasonic output.Do not let it come in contact with tissues other than the target tissue.Olympus will continue to monitor the field performance of the device.

• Brand Name: UNKNOWN THUNDERBEAT HANDPEICE
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): UNKNOWN; unknown; unknown, unknown UNKNO WN; JA UNKNOWN
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 13122640
• MDR Text Key: 288191323
• Report Number: 9610773-2021-00370
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ESG-400, 13171W130007
• Patient Outcome(s): Required Intervention; Other