MAUDE Adverse Event Report: MEDLINE RENEWAL COVIDIEN; LF1212A

Catalog Number LF1212A

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unspecified parathyroid procedure, two reprocessed covidien ligasure¿ small jaw instruments would not seal properly.Reportedly, this extended the procedure for 45 minutes requiring additional anesthesia for the patient.The procedure was successfully finished and there was no effect on the patient's status/stability as a result of this incident.Due to the reported extension of the procedure time and need for additional anesthesia, this medwatch is being filed.The devices were returned for evaluation.The medline renewal packaging, where lot information is printed, were not returned.Upon visual and functional inspection of the returned devices, the reported issue was confirmed and a corrective action was initiated.The root cause was corrosion of the ceramic isolation dots, found on the sealing part of the devices.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that two reprocessed covidien ligasure¿ small jaw instrument would not seal properly during a parathyroid procedure resulting in patient requiring additional anesthesia due to a 45-minute extension of the procedure.

• Brand Name: COVIDIEN
• Type of Device: LF1212A
• 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: 8465123
• MDR Text Key: 145770930
• Report Number: 3032391-2019-00004
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888277664173
• UDI-Public: 10888277664173
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF1212A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/13/2019
• 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