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

Model Number LF1212AR

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

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 Description

It was reported that the ligasure small jaw device was found to be non-functional.

• Brand Name: MEDLINE
• Type of Device: LIGASURE SMALL JAW FOR FORCETRIAD ONLY
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756 1876
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 11342894
• MDR Text Key: 232623559
• Report Number: 3032391-2021-00001
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: LF1212AR
• Device Catalogue Number: LF1212ARH
• Device Lot Number: 422429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 84