MAUDE Adverse Event Report: ETHICON ENDO SURGERY, INC (CINCINNATI) LIGACLIP** CLIP APPLIER

Catalog Number LX207

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.Additional information was requested and the following was obtained: "it was complained that the clip applier was not able to apply a clip properly".Did the device fire malformed clips? if yes, what shape was the clip? was the clip scissored? slightly malformed clips ¿ either scissored, one side of the clip is longer, or one of the legs were bent when applied on the clip, as one side of jaw of the clip applier seems to be slightly thicker/longer, it pushes the case of the clip cartridge out.

Event Description

It was reported that prior to an unknown procedure, the slot for the clip was not deep enough on one of the jaws, and the tip of the inside of the jaws was "sharp".It was complained that the clip applier was not able to apply a clip properly.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.The device will not be returned.

• Type of Device: IGACLIP** CLIP APPLIER
• Manufacturer (Section D): ETHICON ENDO SURGERY, INC (CINCINNATI); 4545 creek rd; cincinnati OH 45242 2803
• Manufacturer (Section G): POST SURGICAL MANUFACTURING; 25 plant ave; hauppauge NY 11788 3804
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5893894
• MDR Text Key: 53602507
• Report Number: 1527736-2016-00022
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LX207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1