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

Catalog Number LT200

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date sent: 10/11/2016.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, the clips were bent, making impossible their utilization.Unknown how case was completed.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).The analysis results of the lt200 cartridge found that it was received empty with a loose clip.The cartridge was noted conforming according to our manufacturing specifications.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: LIGACLIP CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6016483
• MDR Text Key: 57455547
• Report Number: 3005075853-2016-05844
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K830503
• 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: 09/22/2016

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 Expiration Date: 12/31/2020
• Device Catalogue Number: LT200
• Device Lot Number: N4L28E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1