MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number SIGADAPTXL

Device Problems Misfire (2532); Separation Failure (2547)

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

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy procedure, on the third firing of stapler, the jaws of the device lock on tissue and it did not cut at distal end.Manual cut was done to release from the device and suture at distal end.

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy procedure, on the third firing of stapler, the device did not cut at distal end.Manual cut was done to release from the device and suture at distal end.No patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIGNIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8288627
• MDR Text Key: 134463185
• Report Number: 1219930-2019-00577
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543805
• UDI-Public: 10884521543805
• Combination Product (y/n): N
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIGADAPTXL
• Device Catalogue Number: SIGADAPTXL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 01/08/2019; 02/27/2019
• Supplement Dates FDA Received: 02/25/2019; 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR