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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO LL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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DAVIS & GECK CARIBE LTD SURGIPRO LL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE Back to Search Results
Model Number VP-630-X
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/21/2017
Type of Reportable Event Serious Injury
Event or Problem Description
According to the reporter: during bypass ( anastomosis) open procedure, the thread got broke.No component fell into the patient cavity.An x-ray was performed.The surgical time was extended due to the product problem, the product was replaced with the new one (same model, different lot number) in order to complete the case, no injury.Patient status: alive - no injury.
 
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Brand Name
SURGIPRO LL
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key6614104
Report Number9612501-2017-05582
Device Sequence Number757191
Product Code GAW
UDI-Device Identifier20884521038049
UDI-Public20884521038049
Combination Product (Y/N)N
Initial Reporter CountryTU
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/08/2017
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 Date05/31/2021
Device Model NumberVP-630-X
Device Catalogue NumberVP-630-X
Device Lot NumberD6E0882X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/08/2017
Initial Report FDA Received Date06/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
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