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

Catalog Number ER320

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2019.Batch # t9276d.Device analysis: the analysis results found that the instrument er320 was received with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found with no damage.A plastic bag was returned with one malformed clip and one conforming clip inside.In an attempt to replicate the reported incident; the device was cycled, resulting in 1 partially-formed clip due to an anti-backup failure.The remaining 16 clips were fed and formed as intended.Finally, the instrument locked out.In order to evaluate the condition of the device¿s internal components, the device was disassembled.Upon disassembling, the anti-backup lever was found worn out causing the anti-backup failure and the trigger was found to be bent causing the feeding issue.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch/lot number, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, the clip applier did not advance the first time that the handle was squeezed.The second time " it poked through a little".Case completed with another device of the same product code.There were no patient consequences reported.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8708783
• MDR Text Key: 149131603
• Report Number: 3005075853-2019-19851
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012580
• UDI-Public: 10705036012580
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: ER320
• Device Lot Number: T4079F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1