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

Model Number 173016

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 06/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during an unknown procedure, the needle fell out of the jaws twice, requiring the opening of another device to complete the surgery.No adverse events have been reported.

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter: during a thoracic lung wedge resection procedure, the needle fell out of the jaws twice, requiring the opening of another device to complete the surgery.The needle fell into the cavity twice without visible cause.Both times the needle was retrieved.No adverse events have been reported.

• 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: matthew amaral ; 60 middletown ave; north haven, CT 06473 ; 2034926373
• MDR Report Key: 5890202
• MDR Text Key: 53397407
• Report Number: 9612501-2016-00491
• Device Sequence Number: 0
• Product Code: GAM
• Reporter Country Code: US
• PMA/PMN Number: K934738
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J6D0566X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2016
• 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