MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED LIGASURE IMPACT; TISSUE SEALER/DIVIDER

Model Number LF4318

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was returned to medline renewal for evaluation, and we confirmed that it was a medline renewal reprocessed covidien ligasure impact curved, large jaw, open sealer/divider, model lf4318.We performed a thorough inspection and investigation into the incident.Our investigation confirmed that the device did not function as expected, confirming the initial incident report.The root cause of the device failure is unknown and the incident is still under investigation.If additional information becomes available then this report will be updated with the new information.The customer confirmed that no adverse patient consequence or medical intervention was required as a result of the incident.However, due to the reported delay in the procedure, medline renewal is filing this medwatch report.(b)(4).

Event Description

Medline renewal received a report indicating that a reprocessed covidien ligasure impact, model lf4318, sounded intermittent alarms and produced low energy during use.Another reprocessed device was readily available to complete the procedure, therefore no patient harm was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED LIGASURE IMPACT
• Type of Device: TISSUE SEALER/DIVIDER
• 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: 6089384
• MDR Text Key: 59568496
• Report Number: 3032391-2016-00026
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2017
• Device Model Number: LF4318
• Device Catalogue Number: LF4318
• Device Lot Number: 308737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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