MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-08-29 for ROTATABLE OSTIUM PUNCH 8211.661 manufactured by Richard Wolf Gmbh.
[15614012]
A sinus surgery was in progress when two (2) small pieces of the ostium punch broke off in the nasal cavity. The surgeon was able to retrieve one broken piece. The other fragment irrigated out. No pt consequences were reported and no additional treatment was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2000-00052 |
| MDR Report Key | 294164 |
| Report Source | 05 |
| Date Received | 2000-08-29 |
| Date of Report | 2000-07-31 |
| Date of Event | 2000-07-28 |
| Date Facility Aware | 2000-07-28 |
| Report Date | 2000-07-31 |
| Date Reported to Mfgr | 2000-07-31 |
| Date Mfgr Received | 2000-07-31 |
| Device Manufacturer Date | 2000-07-01 |
| Date Added to Maude | 2000-09-06 |
| 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 |
| Manufacturer Contact | JERRY BALOK |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTATABLE OSTIUM PUNCH |
| Generic Name | OSTIUM PUNCH |
| Product Code | KTF |
| Date Received | 2000-08-29 |
| Returned To Mfg | 2000-08-08 |
| Model Number | 8211.661 |
| Catalog Number | 8211.661 |
| Lot Number | P679159 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 284754 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | ROTATABLE OSTIUM PUNCH |
| Baseline Generic Name | OSTIUM PUNCH |
| Baseline Model No | 8211.661 |
| Baseline Catalog No | 8211.661 |
| Baseline ID | P660472 |
| Baseline Device Family | ENT SURGICAL INSTRUMENT |
| 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 | 2000-08-29 |