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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-63-M
Medical Device Problem Code Break (1069)
Health Effect - Clinical Codes Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event 02/04/2020
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 an open hysterectomy procedure, while suturing a portion of the bowel, the needle tip broke and fell into the patient's cavity.This occurred on two units.An x-ray was performed to located the needle tip.Surgical time was extended more than 30 minutes.Another suture was used to complete the case.
 
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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 0101
DO  0101
MDR Report Key9727335
Report Number9612501-2020-00301
Device Sequence Number1965222
Product Code GAP
UDI-Device Identifier10884521085077
UDI-Public10884521085077
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,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/19/2020
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 Model NumberGS-63-M
Device Catalogue NumberGS-63-M
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2020
Initial Report FDA Received Date02/19/2020
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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