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

Catalog Number	HAR36MR
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a lap sleeve, the reprocessed ethicon harmonic ace®+ shears w/o adaptive tissue technology 36cm would not seal a vessel.Per report, the patient had to be administered more anesthesia medication and the procedure went over the expected time.General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.There was no serious injury reported related to this event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was returned for evaluation and the complaint could not be confirmed.Upon testing on sample tissue, the device functioned as expected.A review of the reprocessing record was performed and indicated that all processes were conducted as required.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a lap sleeve, the reprocessed harmonic ace®+ shears w/o adaptive tissue technology 36cm would not seal a vessel.Procedure went over the expected time and patient had to be administered more anesthesia medication.

• Common Device Name: ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8156766
• Report Number: 3032391-2018-00022
• Device Sequence Number: 2745966
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 12/12/2018

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: HAR36MR
• Device Lot Number: 390836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/12/2018
• 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