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

Catalog Number HAR36MRH

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/03/2019

Event Type  Injury  

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 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.

• Type of Device: HAR36M @HARMONIC ACE+ SHEARS W/OUT ADAPT
• 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: 8722053
• MDR Text Key: 148791710
• Report Number: 3032391-2019-00013
• 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: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 74