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

Model Number	GL-66-M
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2017
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, during a prostatectomy procedure, while the surgeon was bunching the vein layer, surgeon noticed that the tip of the needle was broken.They were not able to find the broken part thru inspection and post operative photo could not recognize it either.They completed the case by using another instrument.The patient has no injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample one suture and five needles.One needle was received with the needle tip broken and three needles was received bend.The other needle was received not broken or bend and attached to a suture.Upon microscopic inspection of the needle, instrument marks were observed at the break site of the needle body, needle tip, and the bend site of four of the needles.Unfortunately, because no sealed samples were received, a bend moment test could not be performed.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.The observed instrumentation damages suggested that the needles were grasped improperly at the needle tip during application.Firmly grasping the needle at the tip weakens the needle causing it to bend and/or break.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.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: 7179941
• Report Number: 9612501-2018-00056
• Device Sequence Number: 1261256
• Product Code: GAM
• UDI-Device Identifier: 10884521045446
• UDI-Public: 10884521045446
• 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: Nurse
• Type of Report: Initial,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: 06/30/2021
• Device Model Number: GL-66-M
• Device Catalogue Number: GL-66-M
• Device Lot Number: D6F1169X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 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