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

Model Number MCM30

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t92x8y.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformances were identified.

Event Description

It was reported that during the open hepatectomy surgery, after fired, the clip was not closed and fell off.Removed the falling clip and changed to new one to complete surgery.There was no patient consequence reported.No additional information can be provided.

Manufacturer Narrative

(b)(4).Investigation summary the analysis results found that the mcm30 device was returned with no damage and 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 7 clips as intended.The event described could not be confirmed as the device performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9485322
• MDR Text Key: 207729062
• Report Number: 3005075853-2019-24513
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002482
• UDI-Public: 10705036002482
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

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: 03/06/2024
• Device Model Number: MCM30
• Device Catalogue Number: MCM30
• Device Lot Number: T4088J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/29/2020
• Patient Sequence Number: 1