MAUDE Adverse Event Report: MEDLINE RENEWAL ETHICON; HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM

Catalog Number	HAR36MRH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the teflon pad on the distal jaw of the reprocessed ethicon harmonic ace®+ shears, w/o adaptive tissue technology 36cm, fell off into patient's surgical site.The procedure being done is unknown.No information was provided on how the teflon pad was retrieved from the patient's surgical site.Medical intervention was reportedly required and the patient needed additional anesthesia as a result of the incident.There was no reported serious injury related to this event.Due to the reported event and medical intervention required, this medwatch is being filed.The sample was returned for evaluation and the complaint was confirmed.A potential root cause of the device failure is over-use by the end user.A definitive root cause could not be determined at this time.A review of the device history record was performed for the reported lot and this indicated that all processes were conducted as required at the time the lot was processed.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the teflon pad on the distal jaw of the reprocessed ethicon harmonic ace®+ shears fell off into patient/surgical site.

• Brand Name: ETHICON
• Common Device Name: HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8794547
• Report Number: 3032391-2019-00015
• Device Sequence Number: 3272852
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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 Catalogue Number: HAR36MRH
• Device Lot Number: 413885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/16/2019
• 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: Required Intervention