FDA.reportPublic FDA data

MAUDE MDR 7440353

MDR report key
7440353
Report number
2027111-2018-00116
Event key
0
Event type
3
Date of event
2018-03-16
Date received
2018-04-18
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#

Address
22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CNO11, GELPOINT PATH 5.5CMFERAPPLIED MEDICAL RESOURCESFERCNO111014243011301832R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-04-180

Event Narratives#

N

Patient 1

INVESTIGATION SUMMARY: THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

D

Patient 1

PROCEDURE PERFORMED: "TAMIS TRANSANAL POLYP EXCISION" EVENT DESCRIPTION: "WHILE PASSING AN INSTRUMENT THROUGH THE TROCAR, THE PLASTIC PIECE CAME LOSE FROM THE GELPOINT PATH TROCAR AND FELL INTO THE RECTUM THEN NEEDING TO BE RETRIEVED. PRODUCT WAS NOT BEING USED IN PATIENT AT THE TIME OF THE EVENT. THERE WERE NO MATERIALS LEFT IN THE PATIENT." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM ADVANCED PROCEDURAL IMPLEMENTATION SPECIALIST ON THURSDAY MARCH 22, 2018: "THE COLOR OF THE PIECE DISLODGED WAS CLEAR AND THE SURGEONS REMOVED IT QUICKLY WITH A GRASPER. THERE WAS NOT A NEED TO GET A NEW DEVICE. IT ENDED UP WORKING JUST FINE TO REMOVE THE POLYP, SO NO NEED FOR US TO REPLACE DEVICE." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM ADVANCED PROCEDURAL IMPLEMENTATION SPECIALIST ON TUESDAY MARCH 27, 2018: THE FACILITY DISCARDED THE UNIT. TYPE OF INTERVENTION: "THERE WERE NO MATERIALS LEFT IN THE PATIENT. THE SURGEONS REMOVED IT QUICKLY WITH A GRASPER. THERE WAS NOT A NEED TO GET A NEW DEVICE." PATIENT STATUS: NO PATIENT INJURY. NO PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. NO MEDICAL OR SURGICAL INTERVENTION NECESSARY TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. "NO CHANGE".