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

Model Number 173016

Device Problems Break (1069); Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a bariatric procedure, the scrub tech was unable to remove the needle from the device and the needle broke in the jaws of the device.Additional information has been requested but not yet received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of three devices.A broken needle was found in the jaws of instrument one and two.Under microscopic inspection, both were observed to be broken at the swage and only the needle in instrument one had witness marks on the cone.Witness marks from the needle tip impacting the beveled wall were observed under microscopic inspection for instrument two and three.No sheering on the toggle switches was observed under microscopic inspection for each instrument.The broken needles were removed from the jaws of instrument one and two.The three instruments were then loaded with a needle from the pmv inventory and applied to test media.No difficulty was experienced in loading, unloading or toggling the needle for the three instruments.Product analysis suggests the product was used in a surgical procedure.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 product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Therefore, our investigation was unable to establish a relationship between the device and the reported incident.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: 6237407
• MDR Text Key: 64355764
• Report Number: 9612501-2017-00068
• 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,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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