MAUDE Adverse Event Report: ETHICON ENDO SURGERY, INC (CINCINNATI) LIGACLIP CLIP APPLIER - MEDIUM - 14.6 CM

Catalog Number LX205

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an unknown procedure, the clips fell off and bleeding occurred.The cartridges were broken when the clip applier was introduced.It is unknown how the procedure was completed.No adverse outcome and no other reports were done.

Manufacturer Narrative

(b)(4).Batch # 0702a5757056: the analysis results found that the lx205 device was received in good visual condition.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended.The instrument was fully functional and conforming to our manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.

• Brand Name: LIGACLIP CLIP APPLIER - MEDIUM - 14.6 CM
• 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: 6095598
• MDR Text Key: 60087537
• Report Number: 1527736-2016-00046
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LX205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2007
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1