MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-02-08 for SANI-SCOPE DISPOSABLE ANOSCOPE 82420 manufactured by Galenics (div./coopersurgical).
[255173]
Tip of anoscope broke during insertion. Two (2) pieces were retrieved by physician. Patient refused treatment for a third piece removal at emergency room (original setting not equipped for full rectal exam), stating that the patient had passed it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043419-2002-00001 |
| MDR Report Key | 375676 |
| Report Source | 05 |
| Date Received | 2002-02-08 |
| Date of Report | 2002-02-05 |
| Date of Event | 2002-01-14 |
| Date Mfgr Received | 2002-02-02 |
| Date Added to Maude | 2002-02-11 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR. THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SANI-SCOPE DISPOSABLE ANOSCOPE |
| Generic Name | ANOSCOPE |
| Product Code | FER |
| Date Received | 2002-02-08 |
| 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 | 364764 |
| Manufacturer | GALENICS (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 | 2002-02-08 |