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

Catalog Number MCL20

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested but unavailable: did the jaws of the device sever the artery? did the clip sever the artery? if yes, what was the shape of the clip? was there any patient consequence? if yes, please explain.

Event Description

During the surgery the device severed the artery instead of closing it.The first operator noticed it and solved the problem applying new clips with a different device.

Manufacturer Narrative

(b)(4).The following information was requested but unavailable: did the jaws of the device sever the artery? did the clip sever the artery? if yes, what was the shape of the clip? was there any patient consequence? if yes, please explain.Response: we did not receive any feedback.

Manufacturer Narrative

(b)(4).Batch # p93g53.The analysis results found that the mcl20 device was returned with no damage in the external components.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 12 clips as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Manufacturer Narrative

(b)(4).Batch # p93g53.The analysis results found that the mcl20 device was returned with no damage in the external components.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 12 clips as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7723361
• MDR Text Key: 115279307
• Report Number: 3005075853-2018-11578
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036002465
• UDI-Public: 20705036002465
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2018

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: 08/31/2022
• Device Catalogue Number: MCL20
• Device Lot Number: P4T06J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/03/2018; 10/01/2018
• Supplement Dates FDA Received: 08/13/2018; 10/18/2018
• Patient Sequence Number: 1