MAUDE Adverse Event Report: MEDLINE RENEWAL REPROCESSED HARMONIC SCALPEL; SCALPEL, ULTRASONIC, 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	11/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned for evaluation, and we confirmed that the device had been reprocessed.The reported issue was confirmed.There were no other device defects observed during our investigation.Our investigation also included a review of the device history record.We confirmed that all validated 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 retrieval of the black tissue pad caused a delay in procedure but there were no reported injuries or consequences to the patient.Additionally, no medical intervention was required as a result of the incident.In an abundance of caution, we are filing this medwatch report.
Event or Problem Description
We received a report indicating that the black tissue pad located on the distal tip of a reprocessed harmonic scalpel detached during use.The physician was able to find and remove the tip.

• Brand Name: REPROCESSED HARMONIC SCALPEL
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6404857
• Report Number: 3032391-2017-00007
• Device Sequence Number: 13551958
• 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: 311946
• 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