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

Model Number 173016

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a roux-en-y procedure involving the stomach, the surgeon was toggling the needle though stomach tissue when the needle dislodged from the instrument and fell off in the patient's abdomen.The surgeon retrieved the needle using a laparoscopic hand instrument.There was no patient or user injury or hazard.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one suturing 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, a pmv review of complaint trends, and an evaluation of the returned device.The reported conditions for this incident were needle disengaged, and component disengaged into cavity (retrieved).A needle was received.The visual inspection of the suturing device noted witness marks from the needle tip impacting the beveled wall surrounding the needle receptacle.Some plastic shearing of the toggle switch was noted.The visual inspection of the needle noted no witness marks.A pmv needle was loaded onto the device.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.No difficulty was experienced in loading, unloading, or toggling the needle.Visual and functional testing of the returned product confirmed the product met 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.Trending: a review of the current historical complaint data reveals that this failure mode and/ complaint mode (needle disengaged) was identified as a trend on (february 2016).Trending: a review of the current historical complaint data reveals that this failure mode and/ complaint mode (component disengaged into cavity (retrieved)) was identified as a trend on (december 2016).The file was concluded to be tested satisfactorily as the device was found to meet all visual and functional test specifications.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: 6217851
• MDR Text Key: 63871221
• Report Number: 9612501-2017-00001
• 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: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J6F2931X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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