MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformance's were identified.

Event Description

It was reported that during a lysis of adhesions procedure, the jaw of the device broke off and fell into the patient.The pieces of the jaw were found and removed.The procedure was completed with a like device with no patient consequences were reported.

Manufacturer Narrative

(b)(4).Date sent: 3/13/2020.D4: batch # t9542h.Investigation summary: the analysis results found that the el5ml device was received with the jaw broken.No functional test was performed due the condition of the device.The device was disassembled, and 4 clips were found inside the clip track.It is possible that the damage was due to improper handling of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9696591
• MDR Text Key: 203503897
• Report Number: 3005075853-2020-00956
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• 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: T9542H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 02/17/2020
• Patient Sequence Number: 1