MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SUR ENDO GIA* UNIVERSAL 12MM SINGLE USE INST; DISPOSABLE SURGICAL STAPLING DEVICE

Catalog Number 030449

Device Problems Bent (1059); Failure to Form Staple (2579); Material Deformation (2976)

Patient Problem Tissue Damage (2104)

Event Date 08/13/2014

Event Type  Injury  

Event Description

Procedure type: gastrectomy; according to reporter: customer stated that after they closed the gastric tissue, the stapler was cleaned, and then closed it again to the proper position.After it was fired, the stapler anvil was bent and deformed, and the staples didn't form b shape, however, the blade smoothly cut through the tissue.The doctor urgently conducted the laparotomy and used johnson johnson tlc100 (blue staple cartridge) to cut and close it.The tissue was smoothly cut off.Medical intervention was not required and surgery time was not extended by more than 30 minutes due to the product problem.No reinforcement material was used in conjunction with the stapling device.The patient is in good condition.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Type of Device: DISPOSABLE SURGICAL STAPLING DEVICE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SUR; 60 middletown avenue; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DI; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy-qa ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 4044902
• MDR Text Key: 4861405
• Report Number: 1219930-2014-00779
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 030449
• Device Lot Number: N4A0336X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 030458, ENDO GIA ROTICULATOR 60-3.5 SULU,; EXP. DATE: 04/2018, K900129; LOT #: N3D0087LX, MANUF. DATE: 04/2013,
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 67