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 with the FDA on 2018-08-09 for PKG, SLIDING LOCK ATRAUMATIC GRASPER 0250080767 manufactured by Stryker Endoscopy-san Jose.

Event Text Entries

[116897523] 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


[116897524] It was reported that the grasper broke during a case. Per additional information received, all pieces were retrieved and the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936485-2018-00575
MDR Report Key7770496
Date Received2018-08-09
Date of Report2018-11-30
Date of Event2018-07-16
Date Mfgr Received2018-07-16
Date Added to Maude2018-08-09
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 Report0

Device Details

Brand NamePKG, SLIDING LOCK ATRAUMATIC GRASPER
Generic NameFORCEPS, GENERAL & PLASTIC SURGERY
Product CodeGEN
Date Received2018-08-09
Catalog Number0250080767
Lot Number15405061
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
10 2018-08-09

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