MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO ROTATING MCA; CLIP, IMPLANTABLE

Model Number ER420

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

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 were identified.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during a laparoscopic sleeve gastrectomy the clips were not forming correctly.They were pretzel like.A similar device was used to complete the case.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2020.D4: batch # t94026.Investigation summary: the analysis results of the er420 device found that it was returned with no damage in the external component and with a clip in the jaws.The clip was removed in order to inspect the jaws and they were found to be misaligned.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed and formed 2 scissored clips.In addition, the device locked out as intended.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.Although it is not possible to conclude how the circumstances occurred, it is known from the history of the instrument that an incorrect/excessive application of torque to the jaws during instrument use creates a misalignment of the tips.In addition, as per the instructions for use, it reads ¿do not excessively twist or torque the instrument jaws when positioning the instrument on a vessel and firing.Excessive twisting or torquing may result in clip malformation." a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2020.H2: additional information received: device received for evaluation on 1/6/2020.Device evaluation anticipated but not yet begun.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9528353
• MDR Text Key: 191850661
• Report Number: 3005075853-2019-24787
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012597
• UDI-Public: 10705036012597
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER420
• Device Catalogue Number: ER420
• Device Lot Number: T94M2P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Date Manufacturer Received: 01/17/2020
• Patient Sequence Number: 1