MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when closing vaginal cuff during a laparoscopically assisted vaginal hysterectomy, the device was loaded and entered the cavity to start suturing the vaginal cuff.When they went to pass the needle, the needle broke and got stuck in the tissue.It was stated that the needle was stuck in the tissue and would have been too hard to retrieve without damaging tissue.They had to bring an x-ray machine to locate the component.This resulted to an extended surgical time to thirty minutes or more.They chose to leave the needle in.

Manufacturer Narrative

Evaluation summary post market vigilance (pmv) led an evaluation of three devices.Device one and device two were returned loaded with a needle and, closed jaws of device properly parked in single use loading unit (sulu) retainer.The visual inspection of the returned products noted through microscopic evaluation that no witness marks from the needle tip impacted the beveled walls.The returned instruments were found to function properly and test needles remained intact.No difficulty was experienced in loading, unloading or toggling the test needles in the returned instruments.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8356451
• MDR Text Key: 136715382
• Report Number: 9612501-2019-00300
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10884521100008
• UDI-Public: 10884521100008
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• 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: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention