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

Catalog Number LF1837CRH

Device Problems Dull, Blunt (2407); Difficult to Open or Close (2921)

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

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the jaws of the reprocessed covidien ligasure blunt tip, sealer/divider, nano-coated, compatible with ft10 generator 37cm, would not fully open during an unspecified general laparoscopic case.It was added that the patient was administered additional anesthesia and overall procedure time was extended beyond expected as a result of the time needed to obtain a new instrument.General anesthesia was used; however, 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 or follow up care reported related to the event.Due to the reported device failure and the reported need for additional anesthesia resulting in procedure time extension, this medwatch is being filed.The sample was returned for evaluation and it was observed that there was a small staple lodged inside the device jaws.The source of the staple could not be confirmed.The device had been reprocessed one time.A review of the device history record was performed and this indicated that all processes were conducted as required at the time the reported lot was processed.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 jaws of the reprocessed covidien ligasure blunt tip would not fully open during a laparoscopic case.Additional anesthesia was required and procedure time extended beyond expected.

• 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: 9368893
• MDR Text Key: 190750392
• Report Number: 3032391-2019-00027
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

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 Expiration Date: 05/31/2022
• Device Catalogue Number: LF1837CRH
• Device Lot Number: 416976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• 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