MAUDE Adverse Event Report: MEDLINE RENEWAL ULTRASONIC SCALPELS

Model Number	HAR36M
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was not returned for evaluation.It cannot be confirmed that the device was reprocessed.However, the lot number was provided, and a review of the reprocessing records was performed.All processes were conducted as required prior to release.The reported issue was could not be confirmed, as the device was not returned.The user facility confirmed that the pad was retrieved from the patient at the time of the procedure; general anesthesia was used; however there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident we do not have enough information to determine the root cause of the failure at this time, however if more information is provided then this report will be updated.However, in an abundance of caution, we are filing this medwatch report.
Event or Problem Description
We received a report indicating while using a reprocessed harmonic scalpel, the black tissue pad located on the distal tip, detached during use.

• Brand Name: ULTRASONIC SCALPELS
• Common Device Name: ULTRASONIC SCALPELS
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 6640780
• Report Number: 3032391-2017-00016
• Device Sequence Number: 13698394
• 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): 06/13/2017

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: 01/31/2020
• Device Model Number: HAR36M
• Device Lot Number: 321575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/14/2017
• 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