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

Catalog Number ER420

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.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.The lot/batch was not provided; therefore, the manufacturing record evaluation could not be performed.Additional information received: it was difficult to open the joe of the device, but the surgeon could somehow open without vascular injury.The surgeon tried to use the device outside of the patient, the joe was not able to open.He used the replacement and finished the procedure.This operation was ltg.

Event Description

It was reported that during an unknown procedure, the jaws did not open at the firing.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).Batch # t9208y.Device analysis: the analysis results found that the er420 device was received with the lockout mechanism prematurely activated and with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found to be no damage.Due to the condition of the device, no functional testing could be performed.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, the latch posts were found to be broken and leading the incident reported.In addition, 10 clips were found inside clip track.No conclusion could be reached as to what may have caused the event reported.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot t9228m number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch t9208y 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: 8704064
• MDR Text Key: 149132809
• Report Number: 3005075853-2019-19794
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: ER420
• Device Lot Number: T9228M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Date Manufacturer Received: 07/01/2019
• Patient Sequence Number: 1