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

Catalog Number MCM20

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

Pc-(b)(4).Batch # unk.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you please clarify, when the mcm20 clip applier was "cutting rather than clipping during the case." were the jaws of the device cutting? or were the clips themselves cutting? what was done to address the issue? were there any patient consequences?.

Event Description

The multiclip applier was cutting rather than clipping during the case.Procedure: unknown.

Manufacturer Narrative

(b)(4).Batch # r9498m.Additional information: clip applier malfunctioned instead of clip being deployed vessel was partially cut.This was a vessel off axillary vein, so bleeding have been profuse.Small cuff of vessel still present, so managed to tie using sutures in this case but would have been more of a problem if clip had been attempted closer to axillary vein.Opened a new pack to complete the case (used mcm20, lot r40w4r).Device analysis: the analysis results found that the device was returned with a clip in the jaws.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 10 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: 8121374
• MDR Text Key: 129185637
• Report Number: 3005075853-2018-14719
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• 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
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: MCM20
• Device Lot Number: R40Z4W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 12/14/2018
• Patient Sequence Number: 1