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

Catalog Number HAR36MR

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

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 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.

• Type of Device: ETHICON HARMONIC ACE®+ SHEARS W/O ADAPTIVE TISSUE TECHNOLOGY 36CM
• 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: 8156766
• MDR Text Key: 130492613
• Report Number: 3032391-2018-00022
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/16/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other