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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, POLYPROPYLEN
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DAVIS & GECK CARIBE LTD SURGIPRO LL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN Back to Search Results
Model Number VP-706-X
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/17/2021
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, when in vessel anastomosis on an open procedure, the thread of several devices broke.The defect was seen on two different model number.To resolve the issue, the surgeon used a device with a different size.There was no patient injury.
 
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Brand Name
SURGIPRO LL
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DR  0101
MDR Report Key12151222
Report Number9612501-2021-01142
Device Sequence Number11690647
Product Code GAW
UDI-Device Identifier10884521038264
UDI-Public10884521038264
Combination Product (Y/N)N
Initial Reporter CountryTU
PMA/510(K) Number
K050947
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/12/2021
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 Date06/30/2025
Device Model NumberVP-706-X
Device Catalogue NumberVP-706-X
Device Lot NumberD0G0599Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/18/2021
Initial Report FDA Received Date07/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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