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

Model Number 173016

Device Problems Break (1069); Detachment Of Device Component (1104); Human-Device Interface Problem (2949)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a total laparoscopic hysterectomy, when sewing the vaginal cuff, the two devices were difficult to unload.The first device was used on the patient when the needle broke and the second device¿s needle would not unload and was never used on the patient.The first device¿s needle fell into abdominal cavity of the patient.An x-ray was performed to locate the component, or confirm that all pieces were located.The surgery time was extended by one hour and twenty three minutes.A new unit was opened to complete the case and the needle was retrieved from patient.

• 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: 7498574
• MDR Text Key: 107729761
• Report Number: 9612501-2018-00950
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 20884521100005
• UDI-Public: 20884521100005
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J7K0467EX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/09/2018
• Date Device Manufactured: 10/05/2017
• 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