MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON POLYSORB 3/0 18 VIOLET CV-25 P/O

Model Number GL33MG

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Intestine surgery.The d-tach threads were used as anastomosis suture (single knot) at intestine.The surgeon has stitched the thread through tissue and was going to pull the needle from thread.The needle peak broke of the needle.The needle peak was in needle holder and the main needle part broke off and fell into situs.A x-ray had to brought into surgery room in order to search for the needle.The surgery time was extended 45-60 minutes.The needle could not retrieved from situs.Another time the needle broke into three pieces and flew through the surgery room.No blood loss, no extension of incision.No change of op.No damage of tissue.

Manufacturer Narrative

(b)(4).

• Brand Name: POLYSORB 3/0 18 VIOLET CV-25 P/O
• Type of Device: POLYSORB 3/0
• 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: 4353262
• MDR Text Key: 12867742
• Report Number: 1219930-2014-01190
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GL33MG
• Device Catalogue Number: GL33MG
• Device Lot Number: B4H0354X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other