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

Model Number 030455

Device Problems Detachment Of Device Component (1104); Misfire (2532); Failure to Form Staple (2579)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during a radical prostatectomy plus urinary diversion and reconstruction/bladder replacement with bowel segments, while they were cutting the intestine to create the reservoir, the stapler was able to fire however, there was a poor staple formation.It was reported that the specialist apply only the first two lines of staples and cut the tissue of the colon ascendant next to the ileocecal valve.The proximal staple line was also incomplete.The part of the recharge also fell into the patient cavity, but was recovered.Tissue damage was also noted due to a new cut made with a device to repair the compromised edges and an anastomosis was performed by hand with sutures.They replaced the unit with an open stapler and sutures.There was no patient injury.

Manufacturer Narrative

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

Event Description

According to the reporter, during a radical prostatectomy plus urinary diversion and reconstruction/bladder replacement with bowel segments, while they were cutting the intestine to create the reservoir, the stapler was able to fire however, there was a poor staple formation.It was reported that the specialist apply only the first two lines of staples and cut the tissue of the colon ascendant next to the ileocecal valve.The proximal staple line was also incomplete.The part of the recharge also fell into the patient cavity, but was recovered.Tissue damage was also noted due to a new cut made with a device to repair the compromised edges and an anastomosis was performed by hand with sutures.They replaced the unit with an open stapler and sutures.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7637402
• MDR Text Key: 112301134
• Report Number: 1219930-2018-03396
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523002867
• UDI-Public: 10884523002867
• Combination Product (y/n): N
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 030455
• Device Catalogue Number: 030455
• Device Lot Number: N7E0910KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention