MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ACE+ SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY; ULTRASONIC SCALPEL, HARMONIC SCALPEL

Model Number HAR36M

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was not returned to medline renewal, however an unused, reprocessed har36m from the same lot that was still sealed in the original medline renewal package was returned for evaluation.Our investigation included both an inspection of the returned device, and a review of the device history record (dhr).During the investigation, the device was subjected to all inspection and testing procedures, and as a result, met all acceptance criteria.In addition, our review of the dhr reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release.The reported issue could not be confirmed at this time.The customer confirmed that no adverse patient consequence or additional medical intervention was required as a result of the incident.However, due to the reported delay in the procedure to obtain a new device, medline renewal is filing this medwatch report.H3 other text : another device from same lot evaluated.

Event Description

Medline renewal received a report indicating that a reprocessed ethicon harmonic ace+ laparoscopic shears without adaptive tissue technology, model har36m, did not connect properly to the generator, and that the device would not activate during use.Another device was readily available to complete the procedure; therefore no patient harm or additional medical intervention was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED ACE+ SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY
• Type of Device: ULTRASONIC SCALPEL, HARMONIC SCALPEL
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6085810
• MDR Text Key: 59423709
• Report Number: 3032391-2016-00040
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 10888277408708
• UDI-Public: 10888277408708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: HAR36M
• Device Lot Number: 307295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention