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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CAPROSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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DAVIS & GECK CARIBE LTD CAPROSYN; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number SC-5780G
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event 05/13/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during laparoscopic cystectomy procedure, while tying fallopian tubes, needle detached from the strand and it fell into the cavity of the patient.X-ray was performed to locate the needle from the abdomen, the needle was found on top of the drapes.Operating room time got prolonged for almost 2 hours extra.
 
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Brand Name
CAPROSYN
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 18750
DO  18750
MDR Report Key8669401
Report Number9612501-2019-01068
Device Sequence Number13985753
Product Code GAM
UDI-Device Identifier20884521034928
UDI-Public20884521034928
Combination Product (Y/N)N
Initial Reporter CountryWA
PMA/510(K) Number
K032586
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/05/2019
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 Date03/31/2021
Device Model NumberSC-5780G
Device Catalogue NumberSC-5780G
Device Lot NumberD8C2217X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/14/2019
Initial Report FDA Received Date06/05/2019
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 Required Intervention;
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