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

Model Number	XX-5202J
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: the issue occurred during lap myomectomy.A suture was used wherein its needle was easily detached.Replaced by a new device to complete the procedure.The surgery was extended by more than 30 minutes.No patient harm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.It was observed that two of the needles were detached from the sutures and three of the needles were attached to the sutures.Two of the needles were observed to be bent at the needle body.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.The root cause of the reported condition was an improperly made code along with an improper execution of in-process controls for material assignment.The product analysis established a relationship between a device failure and the reported incident of incorrect needle.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process improvement has been initiated to prevent this condition from recurring.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: 7252649
• Report Number: 9612501-2018-00193
• Device Sequence Number: 13765648
• Product Code: GAM
• UDI-Device Identifier: 20884521154664
• UDI-Public: 20884521154664
• 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
• Report Date (Section B): 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: XX-5202J
• Device Catalogue Number: XX-5202J
• Device Lot Number: D7K1938X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1