MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-21 for UNKNOWN manufactured by Cook Endoscopy.
| Report Number | 1037905-2019-00620 |
| MDR Report Key | 9215718 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-21 |
| Date of Report | 2019-09-24 |
| Date Mfgr Received | 2019-10-21 |
| Date Added to Maude | 2019-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SCOTTIE FARIOLE |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | COOK ENDOSCOPY |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27105 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT |
| Product Code | PTS |
| Date Received | 2019-10-21 |
| Returned To Mfg | 2019-10-02 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK ENDOSCOPY |
| Manufacturer Address | 4900 BETHANIA STATION RD WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-21 |