MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-10-22 for SANI-SCOPE 72420 manufactured by Coopersurgical, Inc..
[967075]
The event is reported to have occurred in 2008. During an unknown procedure, the tip of the anoscope came off. The tip had to be removed from the patient, manually (fingers or forceps).
Patient Sequence No: 1, Text Type: D, B5
[8243851]
A review of our complaint database was conducted resulting in 2 previous re ported events dating back to 2002. Coopersurgical anticipates the return of the subject device, however, as of this report the device has not yet been returned. This report will be supplemented as new information is learned and/or the subject device is returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2008-00035 |
| MDR Report Key | 1211368 |
| Report Source | 08 |
| Date Received | 2008-10-22 |
| Date of Report | 2008-10-22 |
| Date Mfgr Received | 2008-10-07 |
| Date Added to Maude | 2009-06-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANI-SCOPE |
| Generic Name | ANOSCOPE |
| Product Code | FER |
| Date Received | 2008-10-22 |
| Model Number | 72420 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-10-22 |