MAUDE Adverse Event Report: COVIDIEN TACKER SYSTEM 5 TUBES 1 HNDL; DISPOSABLE SURGICAL STAPLER

Catalog Number OMSTTS

Device Problems Material Fragmentation (1261); Defective Component (2292)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

According to the reporter: the handle was defective.There were breaking pieces.There was unanticipated tissue loss.There was no tissue damage.There was no bleeding reported in excess of 500cc.The case was not extended by more than 30 minutes.Nothing fell into the patient cavity.Additional information has been requested.

Manufacturer Narrative

(b)(4).

• Brand Name: TACKER SYSTEM 5 TUBES 1 HNDL
• Type of Device: DISPOSABLE SURGICAL STAPLER
• Manufacturer (Section D): COVIDIEN; building 911-67; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 3569416
• MDR Text Key: 18622505
• Report Number: 2647580-2013-00690
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K944415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: OMSTTS
• Device Lot Number: P2G0636
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2013
• Initial Date FDA Received: 01/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other