MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON MONOSOF* 2/0 36 BLK ST; NONABSORBABLE NYLON SURGICAL SUTURE

Model Number GNJ283

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: gastrectomy.According to the reporter: during a gastrectomy, the needle tip broke and fell into the cavity and could not be retrieved.It was not found by x-ray.No bleeding.No re-operation.No infection.The last known patient status: under observation.Additional information requested but not yet received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of two devices 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, engineering review of the product, and an evaluation of the returned sample.The initial visual inspection of the sample by the pmv investigator noted that two sutures and two needles were received.One needle was received with the needle tip broken and the other was received bent.The returned sample, as received by medtronic, was found to not meet medtronic quality release specifications after application in the clinical setting and the reported condition was confirmed.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Subsequently, a review of the device complaint history did not display an increased trend.Should new information become available, the file will be re-opened.

• Type of Device: NONABSORBABLE NYLON SURGICAL SUTURE
• 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: 5020872
• MDR Text Key: 23692242
• Report Number: 1219930-2015-00749
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K900531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GNJ283
• Device Catalogue Number: GNJ283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other