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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK
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DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK Back to Search Results
Model Number GS-47-M
Medical Device Problem Codes Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/13/2019
Type of Reportable Event Malfunction
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 laminectomy procedure, the needle tip broke off and went into the patient's cavity while the other half of the needle fell to the or floor.The needle tip in the patient was immediately seen and retrieved by the surgeon and the circulator nurse picked up the other half of the needle on the floor.Another suture was used to complete the procedure.There was no patient injury.
 
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Brand Name
SOFSILK
Common Device Name
SUTURE, NONABSORBABLE, SILK
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 18750
DO  18750
MDR Report Key8412549
Report Number9612501-2019-00492
Device Sequence Number11275559
Product Code GAP
UDI-Device Identifier10884521085039
UDI-Public10884521085039
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K981128
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/12/2019
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 Model NumberGS-47-M
Device Catalogue NumberGS-47-M
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/13/2019
Initial Report FDA Received Date03/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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