MAUDE Adverse Event Report: MEDLINE RENEWAL REPROCESSED HARMONIC SCALPEL; ULTRASONIC SCALPEL, REPROCESSED

Model Number	HAR36M
Medical Device Problem Codes	Material Fragmentation (1261); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned for evaluation.We confirmed it had been reprocessed.The reported issue was confirmed.Additionally, we found that the black tissue pad located at the tip of device had also detached during use.We confirmed that all inspection processes were performed according to specification.The user facility did not notify our firm at the time of the incident, therefore few details surrounding the incident are known at this time.The user facility confirmed that the failure occurred during use, however, no medical intervention, no known patient consequences, and no procedural delay occurred as a result.Therefore, we are filing this medwatch report in an abundance of caution.If additional information regarding the incident becomes available, we will update this report.
Event or Problem Description
A user reported that shortly after beginning use of a reprocessed harmonic scalpel, the generator beeped and displayed an error message to "relax pressure".The device could not be used to complete the procedure.

• Brand Name: REPROCESSED HARMONIC SCALPEL
• Common Device Name: ULTRASONIC SCALPEL, REPROCESSED
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6404856
• Report Number: 3032391-2017-00008
• Device Sequence Number: 674914
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: HAR36M
• Device Lot Number: 307189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention