MAUDE Adverse Event Report: COVIDIEN ENDO STITCH* 10MM SUTURING DEVICE; ENDOSCOPE AND/OR ACCESSORIES

Model Number 173016

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a hysterectomy, the endostitch device dropped the needle twice.After about 5-6 stitches the needle fell out from the jaws of the endostitch.A new package of sutures was opened and were beginning to tie knots when the needle dropped off again.Surgery time was extended more than 30 minutes but no adverse events have been reported as a result.

Manufacturer Narrative

(b)(4).Post marketing vigilance 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.An engineering evaluation, and an evaluation of the returned device.A pmv representative 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.When toggling the device, the jaws did not open completely.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the due to the jaw gap out of specification.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.This failure mode and complaint mode has been identified as a trend and a process enhancement has been initiated.Should new information become available, the file will be re-opened.

Manufacturer Narrative

(b)(4).Post marketing vigilance 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.An engineering evaluation, and an evaluation of the returned device.The needle was not received.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.A pmv representative 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, and toggled without difficulty and needle remained engaged in the jaws.Visual and functional testing of the returned sample confirmed the product did meet quality release specifications that were tested regarding the reported conditions.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.Should new information become available, the file will be amended as appropriate.

• Type of Device: ENDOSCOPE AND/OR ACCESSORIES
• 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: 5080435
• MDR Text Key: 26300940
• Report Number: 9612501-2015-00561
• Device Sequence Number: 0
• Product Code: GAM
• Reporter Country Code: SW
• 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: Followup,Followup
• Report Date: 01/06/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J4B0524X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1