MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON VLOC 180 ESTITCH ABS 2 0 8 LP; ENDOSCOPE AND/OR ACCESSORIES

Model Number VLOCA208L

Device Problems Break (1069); Component Falling (1105)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter the physician was using the endo stitch to close the vaginal cuff when the needle broke into three pieces.Abdomen was searched and x-ray taken.The need to search for broken needle prolonged the surgery.Not seen on x-ray.Vloc 180 absorbable reload was used with endo stitch suturing device.The device was used by a health professional.

• Brand Name: VLOC 180 ESTITCH ABS 2 0 8 LP
• Type of Device: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6304889
• MDR Text Key: 66620000
• Report Number: 1219930-2017-00148
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: VLOCA208L
• Device Catalogue Number: VLOCA208L
• Device Lot Number: N5H0750WX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention