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

Model Number EL5ML

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Ethicon endoscopic clip applier el5ml not functioning properly per surgeon.No harm to patient.Lot u93t9l, exp 2/28/2025.

• Brand Name: LIGAMAX ENDOSCOPIC CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 10270266
• MDR Text Key: 198702178
• Report Number: 10270266
• 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: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Lot Number: U93T9L
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28470 DA