UNKNOWN_ENDOSCOPY_PRODUCT UNK_END

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-27 for UNKNOWN_ENDOSCOPY_PRODUCT UNK_END manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[91087871] The device manufacture date is not known at this time. However, should it become available it will be provided in future reports. Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


[91087872] It was reported that the device was continuously activating.
Patient Sequence No: 1, Text Type: D, B5


[114853999] Alleged failure: the customer reported that the wand was firing before any button was pressed. The failure alleged in the complaint record was not confirmed/duplicated during the product investigation. Based on the functional inspection, the probe operated normally upon receipt the customer alleged claim of (wand was firing before any button was pressed) unable to duplicate during testing. The probable root cause/s could be a button stuck on firing position, button inadvertently pressed, probe shorted or defective probe output, defective pcb. A footswitch also can used to activate the rf probe, therefore, use of the footswitch can also be considered a possible root cause. The product was returned for investigation and the reported failure mode was confirmed. The reported failure mode will be monitored for future reoccurrence. Gtin: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[114854000] It was reported that the device was continuously activating.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2017-01016
MDR Report Key6983905
Date Received2017-10-27
Date of Report2018-05-04
Date of Event2017-09-29
Date Mfgr Received2017-09-29
Device Manufacturer Date2017-07-13
Date Added to Maude2017-10-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. VALERIE ESTRADA
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY-SAN JOSE
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal Code95138
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameUNKNOWN_ENDOSCOPY_PRODUCT
Generic NameUNKNOWN
Product CodeGEN
Date Received2017-10-27
Returned To Mfg2018-01-03
Catalog NumberUNK_END
Lot Number17194AE2
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY-SAN JOSE
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-27

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