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

Catalog Number ER320

Device Problems Fitting Problem (2183); Material Integrity Problem (2978)

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

Event Date 08/04/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic cholecystectomy operation, at the cystic artery and ¿choledoch¿ clip applying clip was applied awry and fell down to the abdominal and when clip jaws closed clip was oblique and cannot fit on the vessel.

Manufacturer Narrative

(b)(4).Was clip fed sideways? no.Was clip malformed? yes.Did clip fall off of vessel after being applied? it was observed that some clips fall of vessel.Was there any bleeding? no.If bleeding, please quantify amount of bleeding na.Patient status is ok.The er320 device was returned with the jaws yielded.In an attempt to replicate the reported incident the device was functionally evaluated.Upon firing of the device, the remaining clips were ejected due to the condition of the jaws; finally the instrument locked out as intended.Possible causes for the found condition of the yielded jaws may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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: 4040678
• MDR Text Key: 15364196
• Report Number: 3005075853-2014-05971
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: ER320
• Device Lot Number: K4D72R
• Other Device ID Number: BATCH # K91E6P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2013
• 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