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

Model Number	GL-182-M
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	11/28/2016
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, during anastomosis and reinforcement in a rectal tumor surgery, after the second stitch in a u shape and the suture was tied.They noticed a 1 mm defect on the needle and the stitches broke through the needle holder.They also confirmed thru x-ray that there was no broken needle in the stump of the anastomosis and there was no metal foreign body retained in the abdominal cavity and anastomotic mouth.They washed the abdominal cavity to prevent retention of small metal.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7679404
• Report Number: 9612501-2018-01279
• Device Sequence Number: 13781968
• Product Code: GAM
• UDI-Device Identifier: 10884521045071
• UDI-Public: 10884521045071
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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 Model Number: GL-182-M
• Device Catalogue Number: GL-182-M
• Device Lot Number: D4K2438X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 10/03/2018
• 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: Required Intervention
• Patient Age: 68 YR