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

Catalog Number ER320

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2014

Event Type  malfunction  

Event Description

The sales rep reported that during a laparoscopic cholecystectomy without a cholangiogram procedure, when firing the device with torque the clip would deploy fine, but the following clip was bent; it appeared partially closed.The surgeon would fire the device with torque and then fire the device outside.This clip was like it was off track.All clips used appeared fine in the patient.The case was completed with this same device.There were no patient consequences reported.The device has been discarded.

Manufacturer Narrative

(b)(4); device was not returned for evaluation.Additional information was requested and the following was obtained: was the clip not feeding completely into the jaws of the device? was the clip feeding slowly into the jaws of the device? did the clip feed sideways into the jaws? did more than one clip feed into the jaws? the clip fed into the jaws slowly after the subsequent firing and looked as though it had partially been fired.

• 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: 3873040
• MDR Text Key: 4571436
• Report Number: 3005075853-2014-04003
• 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
• Report Date: 05/21/2014

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 Catalogue Number: ER320
• Device Lot Number: L4EE41
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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