MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number GSJ-33-M

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when the needle was counted at the end of the procedure, the nurse noticed that one was short.An x-ray was performed but the needle was not found.The surgical time was extended by more than 30 mins.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of three devices.A visual inspection of the returned product noted fourteen needles and three retainers.All of the three retainers had five witness marks in parking foam which supports that at the time of manufacture, all five needles were present in each retainer.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.A definitive root cause could not be determined with regard to the reported condition.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOFSILK
• Type of Device: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7630876
• MDR Text Key: 112079254
• Report Number: 9612501-2018-01176
• Device Sequence Number: 1
• Product Code: GAP
• UDI-Device Identifier: 20884521085302
• UDI-Public: 20884521085302
• Combination Product (y/n): N
• PMA/PMN Number: K981128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: GSJ-33-M
• Device Catalogue Number: GSJ-33-M
• Device Lot Number: D8A2153X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention