MAUDE Adverse Event Report: MEDLINE RENEWAL COVIDIEN; LF1212A

Catalog Number	LF1212A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: LF1212A
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• MDR Report Key: 8465123
• Report Number: 3032391-2019-00004
• Device Sequence Number: 11224290
• Product Code: NUJ
• UDI-Device Identifier: 10888277664173
• UDI-Public: 10888277664173
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: LF1212A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other