MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC LIGAMAX; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problem Misfire (2532)

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

Event Date 06/03/2021

Event Type  malfunction  

Event Description

Clips were not firing correctly.A new clip applier was opened as a replacement to complete the procedure.Failed clip applier had patient contact but no patient harm.Manufacturer response for 5ml endo clip applier, (brand not provided) (per site reporter).The representative was notified, who said she would submit a report to the quality team.

• Brand Name: LIGAMAX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 11990679
• MDR Text Key: 255925201
• Report Number: 11990679
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2021

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: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: V94D19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA