PKG, SLIDING LOCK ATRAUMATIC GRASPER 0250080767

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-07 for PKG, SLIDING LOCK ATRAUMATIC GRASPER 0250080767 manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[132296245] 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


[132296246] It was reported that a piece of the grasper remained inside of the patient. Please note that the surgeon elected not to perform the xray.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2019-00006
MDR Report Key8224237
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-01-07
Date of Report2019-02-28
Date of Event2018-12-11
Date Mfgr Received2018-12-11
Date Added to Maude2019-01-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. CHESTER REBUGIO
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 Report3

Device Details

Brand NamePKG, SLIDING LOCK ATRAUMATIC GRASPER
Generic NameFORCEPS, GENERAL & PLASTIC SURGERY
Product CodeGEN
Date Received2019-01-07
Catalog Number0250080767
Lot Number15427331
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
101. Other 2019-01-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.