MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-09-26 for SANI-SCOPE 82420 manufactured by Galenica(div./coopersurgical).
[211198]
The one inch tip of the anoscope obturator component broke free and fell into patient's rectum. The tip was removed immediately via forceps. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043419-2001-00001 |
| MDR Report Key | 353605 |
| Report Source | 05 |
| Date Received | 2001-09-26 |
| Date of Report | 2001-09-26 |
| Date of Event | 2001-09-05 |
| Date Mfgr Received | 2001-09-05 |
| Date Added to Maude | 2001-10-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS WILLIAMS |
| Manufacturer Street | 15 FOREST PARKWAY |
| Manufacturer City | SHELTON CT 06484 |
| Manufacturer Country | US |
| Manufacturer Postal | 06484 |
| Manufacturer Phone | 2039296321 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANI-SCOPE |
| Generic Name | ANOSCOPE |
| Product Code | FER |
| Date Received | 2001-09-26 |
| Model Number | 82420 |
| Catalog Number | 82420 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 342824 |
| Manufacturer | GALENICA(DIV./COOPERSURGICAL) |
| Manufacturer Address | 80 RUE ST- EDOUARD ST. LIBORIE, QUEBEC CA J0H 1R0 |
| Baseline Brand Name | SANI-SCOPE |
| Baseline Generic Name | ANOSCOPE, NON-POWERED |
| Baseline Model No | 82420 |
| Baseline Catalog No | 82420 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 180 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K861017 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2001-09-26 |