MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON VLOC 180 ESTITCH ABS 0 8 LOOP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number VLOCA008L

Device Problem Component Falling (1105)

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

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

(b)(4) according to the reporter: lap assisted vaginal hysterectomy (lavh) involving the vaginal cuff.The needle would not stay in endo stitch device.Loading product was no issue.First instrument, needle fell out approx.3/4 of way through cuff.A second device was opened along with additional needle to close remainder of cuff.Only 2 throws were needed and needle came out while making second throw.Surgeon had concern with closure and bladder doing a cystoscopy which is not routine for her delaying her case, delaying her next case, and delaying her clinic patients in office.She was not happy and has chosen to close from below moving forward b/c she is so sick of the needle falling out every case.The device was used in the patient.There was no patient injury or hazard.The sales rep was present during the case.

Manufacturer Narrative

(b)(4).Device evaluated by mfr?: post market vigilance (pmv) led an evaluation of two devices.No visual abnormalities were noted for both devices.Both instruments were loaded with a needle from the post marketing vigilance (pmv) inventory and applied to test media.No difficulty was experienced in loading, unloading, or toggling the needle for both instruments.Product analysis suggests the product was used in a surgical procedure.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.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.

• Brand Name: VLOC 180 ESTITCH ABS 0 8 LOOP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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 ; 2034926373
• MDR Report Key: 6236498
• MDR Text Key: 64274119
• Report Number: 1219930-2017-00034
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091087
• 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: 12/14/2016

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 Expiration Date: 03/31/2021
• Device Model Number: VLOCA008L
• Device Catalogue Number: VLOCA008L
• Device Lot Number: N6C0844X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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
• Treatment: ENDO STITCH 10MM SUTURING DEVICE