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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE Back to Search Results
Model Number VP-733-X
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
During a coronary artery bypass graft procedure, the device thread broke.They changed the device to complete the case and resolve the issue.The patient is alive with no injury.
 
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Brand Name
SURGIPRO II
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 Key6843101
Report Number9612501-2017-06076
Device Sequence Number712211
Product Code GAW
UDI-Device Identifier20884521038780
UDI-Public20884521038780
Combination Product (Y/N)N
Initial Reporter CountryRP
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) 08/07/2017
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 Date05/31/2020
Device Model NumberVP-733-X
Device Catalogue NumberVP-733-X
Device Lot NumberD5E1602X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/07/2017
Initial Report FDA Received Date09/05/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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