MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE; LIGASURE SMALL JAW FOR FORCETRIAD ONLY

Model Number	LF1212AR
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, during a hemorrhoidectomy procedure, the ligasure small jaw device was found to be non-functional.A different device was required to be obtained and used for the procedure.Reportedly, the procedure was extended by twenty (20) minutes and the patient required the administration of additional anesthesia to complete the procedure.There was no serious injury or adverse patient impact related to the incident.No sample was returned for evaluation.A root cause for the reported incident was unable to be determined.Due to the need for medical intervention to administer additional anesthesia to complete the procedure, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the ligasure small jaw device was found to be non-functional.

• Brand Name: MEDLINE
• Common Device Name: LIGASURE SMALL JAW FOR FORCETRIAD ONLY
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756 1876
• MDR Report Key: 11342894
• Report Number: 3032391-2021-00001
• Device Sequence Number: 12011212
• Product Code: NUJ
• UDI-Device Identifier: 10888277664173
• UDI-Public: 10888277664173
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LF1212AR
• Device Catalogue Number: LF1212ARH
• Device Lot Number: 422429
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/18/2021
• 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
• Patient Age: 45 YR
• Patient Weight: 84