MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-05-14 for SICKLE KNIFE, POINTED TIP 8211.90 manufactured by Richard Wolf Gmbh.
[134502]
A pt was in an outpatient surgical center for: bilateral endoscopic frontal ethmoid maxillary and left sphenoid sinus surgery. A pointed-tip sickle knife was being used when a "snap" was heard and the blade of the knife was found to be missing. The surgeon could not visually locate it. X-rays were taken and tip was located. Following extraction of the loose blade, a cerebral spinal fluid leak was seen. The surgeon attempted to patch the leak, but it continued. The pt was then admitted for placement of a lumbar drain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1998-00021 |
| MDR Report Key | 167654 |
| Report Source | 05,06 |
| Date Received | 1998-05-14 |
| Date of Report | 1998-04-15 |
| Date of Event | 1998-04-09 |
| Date Facility Aware | 1998-04-09 |
| Report Date | 1998-04-15 |
| Date Reported to FDA | 1998-04-15 |
| Date Reported to Mfgr | 1998-04-15 |
| Date Mfgr Received | 1998-04-15 |
| Date Added to Maude | 1998-05-19 |
| 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 | SICKLE KNIFE, POINTED TIP |
| Generic Name | SICKLE KNIFE, POINTED TIP |
| Product Code | KTG |
| Date Received | 1998-05-14 |
| Model Number | 8211.90 |
| Catalog Number | 8211.90 |
| 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 | 158947 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFROZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | SICKLE KNIFE |
| Baseline Generic Name | SICKLE KNIFE |
| Baseline Model No | 8211.90 |
| Baseline Catalog No | 8211.90 |
| Baseline ID | NA |
| Baseline Device Family | ENT KNIFE |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 1998-05-14 |