MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GLS-321
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the end of the needle broke in the patient during use.They have to look for the end of the needle and it delayed the end of the surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the end of the needle broke in the patient during bowel anastomosis.They have to look for the end of the needle and it delayed the end of the surgery.X-ray was performed to locate the needle.The needle was retrieved.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7960187
• Report Number: 9612501-2018-01799
• Device Sequence Number: 1571847
• Product Code: GAM
• UDI-Device Identifier: 20884521045641
• UDI-Public: 20884521045641
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: GLS-321
• Device Catalogue Number: GLS-321
• Device Lot Number: D7H2425X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other