MAUDE Adverse Event Report: COVIDIEN ENDO STITCH* 10MM SUTURING DEVICE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Sticking (1597); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

According to the reporter, sometimes the device would jam after the first use, sometimes the transfer of the needle from one side to the other could not be done and sometimes the needle was crooked.Additional information has been requested but not yet received.

Manufacturer Narrative

Evaluation summary: post marketing vigilance (pmv) received two devices, opened by the account with the appropriate display box and blister packaging in an undamaged condition.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, and an evaluation of the returned device.Instrument 1 was observed to have a bent needle in the jaw.Witness marks were observed on the cones of the needle.No witness marks were observed on the bevel wall of the instrument.No sheering on the toggle switches was observed.The needle was unloaded from the jaws of instrument 1.Both instruments were loaded with a needle from the post marketing vigilance (pmv) inventory and applied to test media.Pressure was exerted on the needle in all directions from both sides of the jaws during this test in an effort to simulate clinical conditions.The instrument was found to function properly and each needle remained intact.No difficulty was experienced in loading, unloading, or toggling the needle for both instruments.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Replication of the bent needle may occur when the needle is not loaded properly or when the needle is forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately break.The returned sample will be retained according to medtronic standards.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6159511
• MDR Text Key: 62324253
• Report Number: 9612501-2016-01048
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: (01)10884521100008(17)210531(10)J6E2622X
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K934738
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J6E2622X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1