MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 1998-07-28 for DISPOSABLE RECTOSCOPE TUBE 4844.01 manufactured by Rwgmbh.
[15746418]
As a sigmoidoscopy was being done, the rigid plastic tip of the disposable rectoscope tube came off in the pt. The pt was able to pass the plastic piece out rectally. No ill effects were reported concerning the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1998-00046 |
| MDR Report Key | 180504 |
| Report Source | 01,07 |
| Date Received | 1998-07-28 |
| Date of Report | 1998-06-30 |
| Date of Event | 1998-05-06 |
| Date Facility Aware | 1998-05-06 |
| Report Date | 1998-06-30 |
| Date Reported to Mfgr | 1998-06-15 |
| Date Mfgr Received | 1998-06-30 |
| Date Added to Maude | 1998-08-05 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE RECTOSCOPE TUBE |
| Generic Name | DISPOSABLE RECTOSCOPE TUBE |
| Product Code | GBT |
| Date Received | 1998-07-28 |
| Model Number | 4844.01 |
| Catalog Number | 4844.01 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 175531 |
| Manufacturer | RWGMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | DISPOSABLE RECTOSCOPE TUBE |
| Baseline Generic Name | DISPOSABLE RECTOSCOPE TUBE |
| Baseline Model No | 4844.01 |
| Baseline Catalog No | 4844.01 |
| Baseline ID | UNK. |
| Baseline Device Family | DISPOSABLE RECTOSCOPE TUBE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-28 |