MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR

Model Number	USG-400
Medical Device Problem Code	Output above Specifications (1432)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to olympus for evaluation without the reported associated thunderbeat device.The evaluation did not confirm the complaint for cut and coag output too high, or for handpiece overheating.The cut and coag outputs on the generator were within specification.There were no overheating or activation issues observed on test handpieces used during the evaluation of the generator.The generator did have multiple prior u512 open circuit errors and u508 seal and cut short circuit errors recorded in device history.These errors were not duplicated during evaluation.Despite multiple followups with several customer personnel by phone and in writing, it is still not known what was the procedure, the event date, whether or how it was completed, what was done to address the reported burn injury, or the patient¿s current condition.Per the generator instructions manual, possible causes for the u508 and u512 errors are handpiece user handling errors or malfunctions of the attached handpieces.The instruction manual states that when these errors occur, the clinician should immediately remove the handpiece from use, verify or replace the handpiece device, and contact olympus if necessary.The generator instructions manual also states, ¿set the minimum required output level for achieving the target tissue effect.Using a higher output level than required may result in unintended burns, perforation and bleeding of tissue.¿ the generator instruction manual also has directions for functional verification of the generator before every procedure, including output settings, and adds, ¿always inspect the accessories as instructed in the instruction manuals before use.Confirm that the insulation on the transducer cord is not damaged.Do not use an accessory if any irregularity is observed.¿ furthermore, as a preventive measure in the event of generator malfunction, the instruction manual recommends ¿always maintain an alternative means to complete a procedure to avoid interruption of treatment.¿.
Event or Problem Description
The 2 of 3.Olympus was informed that during an unknown procedure involving an unknown model olympus generator and unknown model olympus thunderbeat device, the patient had a liver burn injury.It was reported that the cut and coag output was too high, leading to the thunderbeat handpiece overheating and burning the patient¿s liver.This complaint addresses the second of two possible generator models reported for the event.

• Brand Name: ULTRASONIC GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 7867159
• Report Number: 2951238-2018-00531
• Device Sequence Number: 1678788
• Product Code: LFL
• UDI-Device Identifier: 04953170386817
• UDI-Public: 04953170386817
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K172691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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: USG-400
• Device Catalogue Number: USG-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other