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

Model Number	GL-62-MG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, 2 needles had a tip breakage.One of them has been missing.The procedure was completed with use of another device.No intervention was performed.
Additional Manufacturer Narrative
Based on review of the file, this report was updated from a serious injury to a malfunction.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, as per the additional information received, the event occurred during a neurosurgical procedure.The tips of the needles did not disengage into the patient cavity.No known patient impact or consequence.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively during a neurosurgical procedure, 2 needles had a tip breakage.The tips of the needles did not disengage into the patient cavity.The procedure was completed with use of another device.No intervention was performed.No known patient impact or consequence.

• 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: 7161698
• Report Number: 9612501-2018-00011
• Device Sequence Number: 13827367
• Product Code: GAM
• UDI-Device Identifier: 20884521045412
• UDI-Public: 20884521045412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/05/2018

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: 09/30/2022
• Device Model Number: GL-62-MG
• Device Catalogue Number: GL-62-MG
• Device Lot Number: D7J0706X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 12/24/2017; 02/15/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/18/2018; 03/06/2018
• 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