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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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DAVIS & GECK CARIBE LTD SOFSILK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number 170004
Medical Device Problem Codes Break (1069); Human-Device Interface Problem (2949)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/16/2018
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: occurred during a laparoscopic esophagectomy procedure.During the esophageal wrap, the suture strand kept breaking while the surgeon was trying to tie the knot.In order to resolve the issue and complete the case, opened another box of suture.There was no patient harmed.
 
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Brand Name
SOFSILK
Common Device Name
ENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key7318722
Report Number9612501-2018-00411
Device Sequence Number1455416
Product Code OCW
UDI-Device Identifier10884521126909
UDI-Public10884521126909
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K934738
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 03/06/2018
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 Date02/28/2022
Device Model Number170004
Device Catalogue Number170004
Device Lot NumberJ7B0772X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/16/2018
Initial Report FDA Received Date03/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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