MAUDE Adverse Event Report: MEDLINE RENEWAL ETHICON; HAR36M @HARMONIC ACE+ SHEARS W/O ADAPTIV

Catalog Number	HAR36MR
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that the teflon pads on two reprocessed ethicon harmonic ace®+ shears w/o adaptive tissue technology (36cm) fell off during use.Despite good faith efforts to obtain additional information, the initial reporter was unable or unwilling to provide any further patient, product, or procedural/event details.It is unknown if the teflon pads fell into surgical site and what medical intervention was required to retrieve the piece that fell off from the device, if it fell into the surgical site.Due to the reported incident and in an abundance of caution, this medwatch is being filed.A sample is not available to be returned for evaluation.A root cause cannot be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the teflon pads of two reprocessed ethicon harmonic ace®+ shears fell off during use.

• Brand Name: ETHICON
• Common Device Name: HAR36M @HARMONIC ACE+ SHEARS W/O ADAPTIV
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8510111
• Report Number: 3032391-2019-00006
• Device Sequence Number: 11138406
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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): 03/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: HAR36MR
• Device Lot Number: 393615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/12/2019
• 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: Other