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

Catalog Number ER420

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 05/02/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The analysis results found that the er420 instrument was returned in good visual condition with a clip jammed between the top shroud and the jaws.The clip was removed in order to perform functional testing.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing the device for functionality the device was cycled, fed, and formed seven clips as intended and it ejected ten clips.Finally, it locked out as intended.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: 3984473
• MDR Text Key: 12216416
• Report Number: 3005075853-2014-05493
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Type of Report: Initial
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2017
• Device Catalogue Number: ER420
• Other Device ID Number: BATCH # J9152D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2014
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1