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

Catalog Number ER320

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy with intra-operative cholangiography procedure, the surgeon was attempting to clip the duct and vessel.The device wouldn't load correctly or form clips.The surgeon complained also that the device would spit out clips.There were no patient consequences.Case completed with another device of the same product code.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: how did device "not load correctly?" the clips were falling out after the case did clip feed sideways? no.Did clip slow feed? no.Did clip not load or feed at all? no.Did multiple clips feed or load at same time? no.Did device fire clips onto tissue but clips did not form or close? yes.Clips looked formed but one fell off and another device was used.Was device fired over another clip or hard structure? no.Cystic artery and duct.Was there any torquing or twisting of device? not sure.The er320 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition.Upon cycling the device, it was noted to be empty and locked out.The device is designed to lock out when all the clips have been fired.Due to the condition of the device, no functional testing could be performed.Please note the found condition of the jaws may led dropping/ejected clips.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• 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: 3879127
• MDR Text Key: 4508382
• Report Number: 3005075853-2014-04087
• 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: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2019
• Device Catalogue Number: ER320
• Device Lot Number: L4ED0K
• Other Device ID Number: BATCH # L90K73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2014
• 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