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

Catalog Number ER420

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Additional information received: photos were received for review.Upon visual inspection of three photos, the following was observed: the photos show tissue from front view and a clip was observed.The clip appears to be partially placed in tissue.However, the photos are not clear.Based on the photos the event described cannot be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.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 lap sigma, clips were installed as usual.Shortly before the anastomosis was triggered, the surgeon checked the anatomical structures and found that the attached clips had come loose.It is unknown how procedure was completed.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Batch # t9323t.Investigation summary: the analysis results found that the er420 device was received with no damage in the external components.In addition, 4 clips with gap were received inside of a plastic bag.In an attempt to replicate the reported incident, the device was tested for functionality.Upon cycling, the instrument was noted to be empty and locked out.The device is designed to lock out when all the clips have been fired.Due to the condition of the device, no functional testing could be performed to evaluate the incident reported.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.No conclusion could be reached as to what may have caused the event reported.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9112845
• MDR Text Key: 200443052
• Report Number: 3005075853-2019-22311
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Catalogue Number: ER420
• Device Lot Number: T9341R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1