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

Catalog Number ER320

Device Problems Component Falling (1105); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event date: unknown, assumed 1st day of month that complaint was reported.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that during a laparoscopic cholecystectomy the clips were falling off, loose, falling out of the applier.It was not reported how the procedure was completed.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # p93n1v.Device analysis: the analysis results found that the er320 device was returned with no damage in the external components with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found with no damage.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed, retained and formed the remaining 19 clips as intended.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7404194
• MDR Text Key: 105252690
• Report Number: 3005075853-2018-08991
• Device Sequence Number: 1
• Product Code: FZP
• 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
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: ER320
• Device Lot Number: P4T218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1