MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number SIGTRSB60AMT

Device Problem Separation Failure (2547)

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

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of two devices.Visual inspection of the returned products noted that the pushers were all fired, but the sleds were not fully advanced.The jaws were open.The distal sutures on the anvil and cartridge sides were still anchored on reinforcement material.The anvil clamping mechanism was deformed.Functionally the reloads were loaded into a pmv representative instrument, the interlocks were overridden, and the reload were cycled without hesitation or binding and the distal sutures were released.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 bowed anvil, deformed anvil clamping mechanism, and buckled knife-bar assembly may occur under the following conditions.Application over tissue that is beyond the recommended thickness range.Application with an obstacle incorporated in the jaws.In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly and tissue may not be fully transected.The information booklet which accompanies each product shipment offers the following as a warning and precaution."preoperative radiotherapy may result in changes to tissue.These changes may, for example, cause the tissue thickness to exceed the indicated range thickness for the staple size.Careful consideration should be given to any pre-surgical treatment the patient may have undergone and in corresponding selection of staple size.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 caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparosopic sleeve gastrectomy procedure, the distal suture on the reinforcement material would not break off on 3 reloads causing the surgeon to pull on stapler to remove it after firing.There was no patient injury.

• Brand Name: TRI-STAPLE 2.0
• 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: 8335068
• MDR Text Key: 136006178
• Report Number: 1219930-2019-00842
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521717626
• UDI-Public: 10884521717626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2019

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: 07/31/2021
• Device Model Number: SIGTRSB60AMT
• Device Catalogue Number: SIGTRSB60AMT
• Device Lot Number: N8G0774X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• 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