MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON VLOC 180 ESTCH ABS 2-0 6 LP; SINGLE USE SUTURING DEVICE

Model Number VLOCA206L

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

Patient Problem No Code Available (3191)

Event Date 02/10/2015

Event Type  Injury  

Event Description

According to the reporter, during a hysterectomy procedure, the nurse was unloading the device and only half of the needle was present.After searching for a hour, the missing half of the needle was located on the floor slightly under the bed.Prior to finding the needle, an xray was taken of the patient and it was determined that the needle was not located in the patient.There was no unanticipated tissue loss, no unanticipated extension of the incision by more than 1 inch, no unanticipated blood loss of more than 500cc, no device fell into the patient's cavity and no device fragment left in the patient.Although the surgical time was extended, there was no adverse impact to the patient.The post-operative condition of the patient was stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: VLOC 180 ESTCH ABS 2-0 6 LP
• Type of Device: SINGLE USE SUTURING DEVICE
• 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: 4537972
• MDR Text Key: 5542859
• Report Number: 1219930-2015-00130
• Device Sequence Number: 1
• Product Code: GAM
• 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: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: VLOCA206L
• Device Catalogue Number: VLOCA206L
• Device Lot Number: N3L0130X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 68