MAUDE Adverse Event Report: MEDLINE RENEWAL; HAR36M @HARMONIC ACE+ SHEARS W/OUT ADAPT

Catalog Number	HAR36MRH
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that when the reprocessed ethicon harmonic ace®+ shears, w/o adaptive tissue technology 36cm, were used for sealing, film came off the jaws and stuck to the patient.The procedure being done was an unspecified gynecologic procedure.Film was reportedly left in the patient, as it could not be removed.The patient was reportedly under general anesthesia approximately 15 minutes longer than expected.Due to the reported event, this medwatch is being filed.Two used and one unused sample were returned for evaluation.Tacky blue residue was observed on one of the used device's jaw - on the white pad, the device shaft, and on the jaw hinge.The residue appeared to be from a melted surgical drape or gown.The other used device was inspected and residue was observed but it appeared to have come from the patient and was determined not to be a foreign residue.No issues were observed with the returned unused device.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that when the reprocessed ethicon harmonic ace®+ shears, w/o adaptive tissue technology 36cm, were used for sealing, film came off the jaws and stuck to the patient.

• Common Device Name: HAR36M @HARMONIC ACE+ SHEARS W/OUT ADAPT
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8722053
• Report Number: 3032391-2019-00013
• Device Sequence Number: 2021953
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/21/2019

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: 413882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/21/2019
• 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
• Patient Age: 40 YR
• Patient Weight: 74