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

Model Number 173016

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 05/21/2020

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 laparoscopic hysterectomy procedure, while closing the vaginal cuff, the device needle broke in half and fell into the patient cavity.To resolve the issue, multiple surgeon came to assess and used c arm and x-ray was performed in order to complete the procedure.The needle was finally retrieved after several hours.The surgical time was extended for extra 2-3 hours looking for broken needle.

• 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: 10137261
• MDR Text Key: 194599961
• Report Number: 9612501-2020-00808
• 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: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: 173016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• 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