FDA.reportPublic FDA data

MAUDE MDR 8152843

MDR report key
8152843
Report number
2134070-2018-00113
Event key
0
Event type
3
Date of event
2018-11-01
Date received
2018-12-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. GABRIEL ALFAGEME
Address
5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MULTI CLIP APPLIER LIGACLIP ERCA ROTATING 20 LARGE CLIPSCLIP, IMPLANTABLE, REPROCESSEDSTERILMED, INC.NMJETHER4202065057Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-110

Event Narratives#

N

Patient 1

SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE ARE NO OBSERVED DISCREPANCIES UPON REVIEW OF THE DEVICE HISTORY RECORD. AN EVENT DATE OF (B)(6) 2018 WAS PROVIDED WITH THE EXACT DATE UNKNOWN. THEREFORE, THE FIRST DAY OF THE MONTH WAS USED. (B)(4).

D

Patient 1

IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WITH A MULTI CLIP APPLIER LIGACLIP ERCA ROTATING 20 LARGE CLIPS AND THE CLIPS BECAME SISSORED. THE SURGEON WAS USING THE REPROCESSED CLIP APPLIER AND THE CLIPS SCISSORED, IN WHICH THE TIPS OVERLAPPED CREATING A TWIST. THOSE STAPLES WERE REMOVED, THE STAPLER WAS REMOVED FROM THE FIELD AND A NEW STAPLER THAT WAS NOT PROCESSED WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THIS EVENT HAS BEEN ASSESSED AS A MALFUNCTION.