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

Model Number EL5ML

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Endoscopic multiple clip appler - el5ml was placed in patient's abdomen and the handle would not work properly.Device was then removed and the tip on the end that holds the clip was crossing over incorrectly.

• Brand Name: LIGAMAX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 16067500
• MDR Text Key: 306331623
• Report Number: 16067500
• 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: 12/15/2022,12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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: W7014E
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9490 DA
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Race: White