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

Catalog Number HAR36MR

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Type  malfunction  

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 Description

It was reported that the teflon pads of two reprocessed ethicon harmonic ace®+ shears fell off during use.

• Brand Name: ETHICON
• Type of Device: HAR36M @HARMONIC ACE+ SHEARS W/O ADAPTIV
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 8510111
• MDR Text Key: 142548442
• Report Number: 3032391-2019-00006
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: HAR36MR
• Device Lot Number: 393615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other