MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-26 for COOK MEDICAL SPHINCTEROTOME FS-OMNI-21-260 G56103 manufactured by Wilson-cook Medical.
Report Number | MW5090076 |
MDR Report Key | 9128831 |
Date Received | 2019-09-26 |
Date of Report | 2019-09-25 |
Date of Event | 2019-09-18 |
Date Added to Maude | 2019-09-27 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | COOK MEDICAL SPHINCTEROTOME |
Generic Name | UNIT, ELECTROSURGICAL, ENDOSCOPIC |
Product Code | KNS |
Date Received | 2019-09-26 |
Model Number | FS-OMNI-21-260 |
Catalog Number | G56103 |
Lot Number | W4233633 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | WILSON-COOK MEDICAL |
Manufacturer Address | WINSTON SALEM NC 27105 US 27105 |
Brand Name | MICROKNIFE XL |
Generic Name | UNIT, ELECTROSURGICAL, ENDOSCOPIC |
Product Code | KNS |
Date Received | 2019-09-26 |
Model Number | GTIN 08714729172017 |
Catalog Number | M00532810 |
Lot Number | 22945338 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 2 |
Device Event Key | 0 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Brand Name | ROADRUNNER WIRE GUIDE |
Generic Name | ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY - UROLOGY |
Product Code | OCY |
Date Received | 2019-09-26 |
Model Number | RR-18-260 |
Catalog Number | G23038 |
Lot Number | W4021551 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 3 |
Device Event Key | 0 |
Manufacturer | COOK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-09-26 |