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

Catalog Number MCL20

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

It was reported that during a hepatectomy procedure, while he was firing the clip applier, the clip was not fully deployed.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Cartridge cover out of position.The analysis found that the mcl20 device was received with the cartridge cover out of its intended position; the cover was found to be disengaged from outer wrap, causing that the clips lose their position.This condition cause the clips could not be fed into the jaws.A potential cause is that the cartridge cover was not properly assembled during the manufacturing process.No testing to evaluate the reported malformed clips could be preformed.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: LIGACLIP MCA LARGE 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: 3894585
• MDR Text Key: 4648591
• Report Number: 3005075853-2014-04382
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K820837
• 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: 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: MCL20
• Other Device ID Number: BATCH # K92J8W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2014
• Initial Date FDA Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• 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