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

Catalog Number ER320

Device Problems Bent (1059); Sticking (1597); Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that the er320 device was returned in good visual condition with a clip in the jaws; the clip was removed in order to measure the jaws width and they were found to be within the specification.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled, fed, retained and formed the remaining clips as intended.The reported event could not be confirmed as the device was found to be fully functional.No conclusion could be reached as to what may have caused the reported incident.The batch record was reviewed and no anomalies were noted during the manufacturing process.

Event Description

It was reported that during a laparoscopic cholecystectomy, when firing the device the clip was bent (malformed in shape) and could not be deployed from the device.The surgeon had to pull the clip from the jaws because they were getting stuck.The clip never did make it to the vessel.This was happening with every clip that was fired.A second device was opened and the case was completed with no patient consequences.

Manufacturer Narrative

(b)(4).Information anticipated, but unavailable at this time.

• Brand Name: ROTATING MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3953012
• MDR Text Key: 12323349
• Report Number: 3005075853-2014-05173
• Device Sequence Number: 1
• Product Code: FZP
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2014

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: 01/20/2019
• Device Catalogue Number: ER320
• Device Lot Number: L4E902
• Other Device ID Number: BATCH # L90E0J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 07/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• 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