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 12/02/2022

Event Type  malfunction  

Event Description

82 y/o male with history of bile duct stones.Procedure: laparoscopic cholecystectomy.When the stapler was used in surgery, it misfired.Another one obtained and it misfired.A third was obtained and used without problems.The 2 that misfired had the same lot number.No known harm to the patient, delay with procedure.Manufacturer response for clip, implantable, ligamax (per site reporter) will obtain.Manufacturer response for clip, implantable, ligamax (per site reporter) will obtain.

• Brand Name: LIGAMAX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 16060540
• MDR Text Key: 306273011
• Report Number: 16060540
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2022

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: X95VOJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Sex: Male
• Patient Weight: 82 KG