MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number 88861957-32

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

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

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, during craniotomy, while closing the dura flap layer, the needle tip broke off.Unable to find the needle tip in the x-ray and ended up taking patient to ct scan to identify the needle tip.After identifying the needle, brought the patient back into surgery to remove the needle tip which extends the surgical procedure to 30 minutes or more.

• Brand Name: SURGILON
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: 9176793
• MDR Text Key: 162007719
• Report Number: 9612501-2019-01945
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10884521072749
• UDI-Public: 10884521072749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981582
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 88861957-32
• Device Catalogue Number: 88861957-32
• Device Lot Number: D9E2793Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/10/2019
• Date Device Manufactured: 05/25/2019
• 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