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

Model Number SIGTRS60AXT

Device Problems Entrapment of Device (1212); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, occurred during a laparoscopic sleeve gastrectomy.While stapling the stomach, all three reloads were fired and it was clear that the distal suture did not break and separate from the reload.This caused the buttress material to stick to the reload and tissue.The surgeon pulled the stapler away from the tissue to break free and remove the stapler.There was no issue with the staple line.Esophagogastroduodenoscopy was performed and the staple line was intact with no evidence of leak.The case was completed using a new reload.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 1cm cut line.Functionally the reload was loaded into a pmv representative instrument, the interlock was overridden, and the reload was applied to test media.All remaining staples were placed and the test media was cleanly transected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the partial fire condition with interlock engagement may occur if the firing button had been partially compressed and then the open button was pressed after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the loading unit from firing a second time.Replication of the unreleased sutures may occur if the firing sequence is not completed.In this situation, the internal hinges which release the sutures may not engage fully and reinforcement material may not deploy properly.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7324247
• MDR Text Key: 101900147
• Report Number: 1219930-2018-01380
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

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 Model Number: SIGTRS60AXT
• Device Catalogue Number: SIGTRS60AXT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 03/17/2018; 03/17/2018
• Supplement Dates FDA Received: 04/04/2018; 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1