MAUDE Adverse Event Report: MEDLINE RENEWAL COVIDIEN; LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR

Catalog Number LF1837CRH

Device Problem Defective Component (2292)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the reprocessed covidien ligasure blunt tip, sealer/divider, nano-coated, compatible with ft10 generator 37cm "failed" during an unidentified procedure.As a result of the instrument failure, the patient was left on the table with an open incision and the overall procedure time was extended beyond expected, as a new instrument had to be collected.The patient reportedly required additional anesthesia as a result of the incident.There was no serious injury reported related to this event.Due to the reported event, this medwatch is being filed.The device was returned for evaluation.Upon inspection of the received device, it was observed that one of the power pins was bent.During simulated use, the device appeared to function correctly as the appropriate tones sounded on the generator.After the sealing cycle was complete, it was observed that no energy had transferred to the distal end of the device, as the test media was not sealed.The device did not function as expected and the reported issue was confirmed.The device had been reprocessed one time.The lot number associated with the device was not reported and the package/label was not returned with the device.A review of the device history record / internal stock check could not be performed as no lot information was provided a definitive 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 the reprocessed covidien ligasure blunt tip "failed" and patient required additional anesthesia since procedure extended beyond expected time.

• Brand Name: COVIDIEN
• Type of Device: LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR
• 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: 9010461
• MDR Text Key: 170111948
• Report Number: 3032391-2019-00020
• Device Sequence Number: 1
• Product Code: NUJ
• 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: Other
• Type of Report: Initial
• Report Date: 09/12/2019

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: LF1837CRH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/12/2019
• 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