MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ACE+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY; HARMONIC SCALPEL

Model Number	HAR36M
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to medline renewal for evaluation, and we confirmed that it was a medline renewal reprocessed ethicon harmonic ace®+ shears w/o adaptive tissue technology, model har36m.We performed a thorough inspection and investigation into the incident.Our investigation confirmed that the black part of the tissue pad located on the distal tip of the device had detached, confirming the initial report.However, medline renewal was unable to re-create the error code to "relax pressure" during our investigation.We concluded that the root cause of black pad detachment from the device was adhesive failure.The ethicon gen 11 generator may display the "relax pressure" error code if too much tissue is placed between the jaws to allow the device to operate properly.The customer confirmed that no adverse patient consequence or additional medical intervention was required as a result of the incident.However, due to the detached component and the reported delay in the procedure required to obtain a new device, medline renewal is filing this medwatch report.(b)(4).
Event or Problem Description
Medline renewal received a report indicating that the generator initiated an error code to "relax pressure" during the use of a reprocessed ethicon harmonic ace+ laparoscopic shears without adaptive tissue technology, model har36m.Then part of the tissue pad located on the distal tip detached from the device and was retrieved by the surgeon.Another device was readily available to complete the procedure, therefore no patient harm or additional medical intervention was required as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED ACE+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY
• Common Device Name: HARMONIC SCALPEL
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6088191
• Report Number: 3032391-2016-00030
• Device Sequence Number: 18985288
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: HAR36M
• Device Lot Number: 305527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2016
• Initial Report FDA Received Date: 11/08/2016
• 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