MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-06-30 for NASAL SCISSORS, STRAIGHT 8211.22 manufactured by Richard Wolf Gmbh.
[65556]
As a sinus surgical procedure was completed, the surgeon noted one blade of the nasal scissors was missing. The part could not be located. The pt was sent for x-rays and then released. While at home the missing blade was coughed up by the pt. X-rays confirmed the foreign body was lodged in the bronchial area. The user facility has not reported any specific injury or other problems for the pt following the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1997-00031 |
| MDR Report Key | 103592 |
| Report Source | 05 |
| Date Received | 1997-06-30 |
| Date of Report | 1997-06-05 |
| Date of Event | 1997-06-04 |
| Date Facility Aware | 1997-06-04 |
| Report Date | 1997-06-05 |
| Date Reported to Mfgr | 1997-06-05 |
| Date Mfgr Received | 1997-06-05 |
| Device Manufacturer Date | 1993-12-01 |
| Date Added to Maude | 1997-07-09 |
| 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 | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NASAL SCISSORS, STRAIGHT |
| Generic Name | NASAL SCISSORS, STRAIGHT |
| Product Code | KBD |
| Date Received | 1997-06-30 |
| Returned To Mfg | 1997-06-10 |
| Model Number | 8211.22 |
| Catalog Number | 8211.22 |
| Lot Number | A-M-S |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3.5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 101923 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | NASAL SCISSORS |
| Baseline Generic Name | NASAL SCISSORS |
| Baseline Model No | 8211.22 |
| Baseline Catalog No | 8211.22 |
| Baseline ID | A-M-S |
| Baseline Device Family | NASAL SCISSORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-06-30 |