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

Catalog Number ER320

Device Problem Bent (1059)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: the clips were fired from the instrument, the surgeon had to remove them as they did not ligate the structure that he was working on.The clips scissored as they were formed in the gun.He attempted 3 times and then asked for the second product.The clips were scissored and did not hold the structure/ vessel that is why it was sent back as a product complaint , a new one was used to complete the procedure with no adverse events.This is all the information i can get from the staff at the hospital.

Event Description

It was reported that during an unknown procedure, the clips bent over each other as the doctor wanted to fire the instrument.The clips were retrieved from the abdomen of the patient.Another like device was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Batch # m9213x.The analysis results of the er320 device found that it was received in good condition.The jaws were inspected and they were found to be in good condition.In addition, 3 clips scissored and 1 gap clip were receive in a plastic bag.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed and formed 14 conforming clips; in addition, the device locked out as intended.During functional testing no scissored clips were noted.No conclusion could be reached as to what may have caused the event reported.A batch record review was performed and no anomalies 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: 5387617
• MDR Text Key: 36770675
• Report Number: 3005075853-2016-00530
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K864102
• 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: 01/21/2016

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: 06/17/2020
• Device Catalogue Number: ER320
• Device Lot Number: M4HU77
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 01/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1