MAUDE Adverse Event Report: COVIDIEN ENDO STITCH* 10MM SUTURING DEVICE; SINGLE USE SUTURING DEVICE

Model Number 173016

Device Problems Failure to Disconnect (2541); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure type: lap gastric roux en y.According to the reporter: following use, the endostitch needle would not release from the handle, and the handle would not open when staff tried to unload it.Handle and needle will be returned still jammed closed.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment fell into the patient.To correct this condition another endostitch handle was opened.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post marketing vigilance concurrently with engineering led an evaluation of one device 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, pmv review of complaint trends and an evaluation of the returned device.The reported condition for this incident was that the endostitch needle would not release from the handle, and the handle would not open when staff tried to unload it.Handle and needle will be returned still jammed closed.The needle was received locked in the jaws and loaded backward.The jaw gap was measured and met specification.No witness marks from the needle tip impacting the beveled wall surrounding the needle receptacle were noted for the device, indicating proper alignment of the jaws when toggling the needle.The needle was removed without difficulty.The subject needle was loaded onto the instrument.The needle was found to function properly when applied through layers of test media.Pressure was exerted on the needle in all directions and from both sides of the jaw to simulate clinical conditions.The needle was loaded and unloaded onto the instrument without difficulty.No difficulty was experienced in loading, unloading, or toggling the needle.Visual and functional testing of the returned sample confirmed the product met quality release specifications that were tested regarding the reported conditions.A review of the device history record indicates this lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened.

• Type of Device: SINGLE USE SUTURING 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: 5008177
• MDR Text Key: 24677252
• Report Number: 9612501-2015-00480
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J5E0859X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1