MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ABS FIXATION DEVICE W/15 TACKS; ABSTACK15

Model Number ABSTACK15

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 10/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: when the first tacking was done, the first tack torn the mesh and it passed through it.Then the mesh material could not be fixed to the tissue only with the tack remained there.Trying again for several times, however, every time the same trouble was duplicated and at last no more tack left in the concerning one.Opened another, however, found still the same failure event occurred repeatedly.Using another of our competitor: medicon was used to complete the case with no problem.

Manufacturer Narrative

(b)(4).

• Brand Name: ABS FIXATION DEVICE W/15 TACKS
• Type of Device: ABSTACK15
• 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 06743 ; 2034925267
• MDR Report Key: 4143097
• MDR Text Key: 12559319
• Report Number: 1219930-2014-00919
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091900
• 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: 10/01/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: ABSTACK15
• Device Catalogue Number: ABSTACK15
• Device Lot Number: N4F0173X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 10/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other