MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA MEDIUM/THICK RADIAL RELOAD; STAPLE, IMPLANTABLE

Model Number EGIARADMT

Device Problems Crack (1135); Sticking (1597); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: low anterior resection.According to the reporter: the device was applied to the distal colon/rectum using the idrive ultra handle.Once around the tissue, the surgeon attempted to fire the stapler.After advancing minimally, the idrive slowed and then stopped.The surgeon checked to ensure no other tissue was in the distal jaws of the stapler.After waiting 30 more seconds, he pressed the blue button to continue firing.The knife blade advance slightly further.He repeated this process two more times until the knife blade would no longer advance.Then, he retracted the knife blade and then opened and removed the reload from the tissue.He then used a disposable handle and reload.The surgeon fired the handle slowly, but after advancing approx.35%, the handle cracked.He allowed a few seconds for the tissue to compress and attempted to slowly squeeze the ring handle but had the same result.He did this a few times until the ring handle no would no longer grab teeth to move the knife forward.He then retracted the knife blade and opened the reload and removed it from the tissue.The surgeon attempted this again with another reload on the idrive handle with same result.He could only get the reload fired approx 35%.Finally, he attempted with a third reload and idrive.The device slowed and then stopped during the firing.He allowed time to compress and advanced the knife blade two more times.On the second attempt, the reload fired completely.Though there was patient involvement, there was no injury to the patient.No reinforcement material was used.There was no unanticipated tissue loss and the incision was not extended by more than an inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes and no device fragment fell into the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned devices.The reported condition for this incident was that during a low anterior resection procedure, the reload partially fired and fired slowly.Visual inspection of the cartridge revealed that the reload was partially fired with the interlock engaged.The anvil clamping mechanism was deformed.The reload was loaded into a pmv representative instrument idrive ultra powered handle 1 and an adaptor for functional testing.The reload loaded, unloaded, rotated, articulated, and opened and closed properly without difficulty.All remaining staples were placed and the test media was cleanly transected.Functional testing confirmed the safety interlock feature successfully prevented the reload from cycling again.The returned reload as received by covidien was found to not meet specifications and the reported condition was confirmed.A review of the device history record indicates this device lot number was released meeting all quality specifications.Replication of the reported condition may occur of the idrive ultra powered handle stops firing before the lower clamp reaches the distal end, which is likely due to the firing force reaching the upper design limit of the endo gia reload.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.A review of complaint data reveals no trend for a device related failure for this condition.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.(b)(4).

• Brand Name: ENDO GIA MEDIUM/THICK RADIAL RELOAD
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4925872
• MDR Text Key: 22505880
• Report Number: 1219930-2015-00589
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 06/25/2015

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: 11/30/2019
• Device Model Number: EGIARADMT
• Device Catalogue Number: EGIARADMT
• Device Lot Number: N4L0345X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1