FDA.reportPublic FDA data

MAUDE MDR 6174386

MDR report key
6174386
Report number
2027111-2016-00885
Event key
0
Event type
3
Date of event
2016-11-10
Date received
2016-12-14
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
WENDY KOBAYASHI
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
1CNO12, GELPOINT PATH 9CMFERAPPLIED MEDICAL RESOURCESFERCNO111013515011235809Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-1410

Event Narratives#

N

Patient 1

THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

D

Patient 1

TAMIS - "TRANSPARENT INSTRUMENT PROTECTOR FELL INTO RECTAL SPACE DURING PROCEDURE. INSTRUMENTS USED WAS 10MM 30DG, ATTRAUMATIC GRASPER AND MINOPOLAR DIATHERMY NEEDLE ELECTRODE. BOTH ANGLED TEM INSTRUMENTS. WE DISCUSSED THE HAPPENING AFTER SURGERY WHERE WE CONCLUDED THAT THE NEEDLE ELECTRODE MAY BE THE CAUSE OF INCIDENT. THE DEVICE IS TAKEN CARE OF AT THE DEPARTMENT FOR PICKUP. NO LIFE THREATENING SITUATION OCCURED AND THE INSTRUMENT PROTECTOR WAS EASY DETECTED AND REMOVED FROM SPACE." PATIENT STATUS - "NO LIFE THREATENING SITUATION OCCURED"

N

Patient 1

INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION ALONG WITH A DISLODGED INSTRUMENT SHIELD, AN INNER COMPONENT OF ONE OF THE TROCARS. UPON INVESTIGATION, ENGINEERING OBSERVED SCRATCH MARKS ON THE INSTRUMENT SHIELD, INDICATING THAT IT HAD COME INTO CONTACT WITH AN INSTRUMENT. THE ROOT CAUSE OF THE DAMAGE TO THE INSTRUMENT SHIELD IS CONTACT WITH AN ANGLED INSTRUMENT. APPLIED MEDICAL'S INSTRUCTIONS FOR USE (IFU) STATES THAT, "EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS, SUCH AS 'J' HOOKS AND CLIP APPLIERS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING." APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE TO 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.