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

Catalog Number ER320

Device Problems Bent (1059); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: additional information requested: can you please clarify the statement you made regarding the device clips were "bent or get stuck".Did the device fire clips that were malformed? yes.Or did "bent" clips fall out of the device without being fired? when the clips were "stuck", did the device not fire clips at all? file will remain same upon review of follow up received from affiliate.The analysis results found that the er320 device was returned with a clip in the jaws; the clip was removed in order to measure the jaws and they were found within specification.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 14 clips as intended.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were noted.As the device was found to be fully functional, it could not be determined 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.

Event Description

It was reported that during a laparoscopic cholecystectomy procedure, the clips fell out of the device, were bent or get stuck.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

• Brand Name: LIGACLIP CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5765293
• MDR Text Key: 49395422
• Report Number: 3005075853-2016-03712
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2021
• Device Catalogue Number: ER320
• Device Lot Number: N4LE5A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1