FDA.reportPublic FDA data

MAUDE MDR 7915548

MDR report key
7915548
Report number
2951238-2018-00581
Event key
0
Event type
3
Date of event
2018-08-17
Date received
2018-09-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CONNIE TUBERA
Address
2400 RINGWOOD AVENUE SAN JOSE CA 95131 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DISPOSABLE HOT BIOPSY FORCEPSDISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGESD-230U-20SD-230U-20V7112Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-2701. R

Event Narratives#

N

Patient 1

THE DEVICE HAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. DESPITE SEVERAL FOLLOWUP ATTEMPTS BY PHONE AND IN WRITING, THERE IS NO FURTHER INFORMATION ON THE TYPE OF PROCEDURE, THE TISSUE PERFORATED, WHAT ROLE THE REPORTED FAILURE TO ACTIVATE PLAYED IN THE PERFORATION, WHETHER THE DEVICE WAS INSPECTED BEFORE USE, THE ADDITIONAL SURGICAL INTERVENTION, THE PATIENT?S CURRENT CONDITION, OR THE CONCOMITANT DEVICES INVOLVED. AS PREVENTIVE MEASURES, THE DEVICE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING AND CAUTION STATEMENTS FOR AVOIDING PATIENT PERFORATION: ?DO NOT INSERT THE INSTRUMENT INTO THE ENDOSCOPE UNLESS YOU HAVE A CLEAR ENDOSCOPIC FIELD OF VIEW. IF YOU CANNOT SEE THE DISTAL END OF THE INSERTION PORTION IN THE ENDOSCOPIC FIELD OF VIEW, DO NOT USE IT. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION? ?DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION? ?DO NOT ANGULATE THE BENDING SECTION OF THE ENDOSCOPE ABRUPTLY WHILE THE DISTAL END OF THE INSERTION PORTION IS EXTENDED FROM THE DISTAL END OF THE ENDOSCOPE. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION? ?ALWAYS OPERATE THE ELECTROSURGICAL UNIT AT THE MINIMUM OUTPUT LEVEL AND FOR THE MINIMUM TIME NECESSARY TO SUCCESSFULLY COMPLETE THE PROCEDURES. EXCESSIVE OUTPUT LEVELS OR TIMES MAY RESULT IN PATIENT INJURY, SUCH AS PERFORATION? ?DO NOT ACTIVATE OUTPUT WHEN THE DISTAL END OF THE ENDOSCOPE IS TOO CLOSE TO OR IN CONTACT WITH THE METAL PORTION AT THE DISTAL END OF THE FORCEPS INSERTION PORTION. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION? AND ?ASPIRATE FLUIDS, SUCH AS MUCUS, THAT ADHERE TO THE DISTAL END OF THE INSERTION PORTION AND BODY CAVITY TISSUES. IF OUTPUT IS ACTIVATED WITH THESE FLUIDS LEFT ATTACHED, IF COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION?. THE INSTRUCTION MANUAL ALSO CONTAINS DIRECTIONS FOR PRE-PROCEDURE INSPECTION OF THE DEVICE, INCLUDING VISUAL AND TACTILE INSPECTION, AND VERIFICATION OF MECHANICAL OPERATION.

D

Patient 1

OLYMPUS WAS INFORMED THAT DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN INITIALLY THOUGHT THE DEVICE WAS NOT ACTIVATING ON THE INTENDED POLYP TISSUE. THE CLINICIAN LATER NOTICED THAT HE HAD PERFORATED PAST THE MUCOSA AND HE WAS ABLE TO SEE THE INTESTINES. THE PATIENT HAD TO BE SENT OUT FOR SURGICAL INTERVENTION. THE PATIENT?S CURRENT CONDITION IS UNKNOWN.