MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-07-13 for KNIFELIGHT 3300-001-000 N/ manufactured by Stryker Instruments.
[126699]
During a carpal tunnel decompression the plastic tip above the knife broke off. Ultrasound performed to determine if foreign body was retained in the wrist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1999-00023 |
| MDR Report Key | 231864 |
| Report Source | 06 |
| Date Received | 1999-07-13 |
| Date of Report | 1999-06-14 |
| Date of Event | 1999-06-07 |
| Date Facility Aware | 1999-06-07 |
| Report Date | 1999-06-14 |
| Date Mfgr Received | 1999-06-14 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1999-07-19 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KNIFELIGHT |
| Generic Name | KNIFE, SURGICAL |
| Product Code | EMF |
| Date Received | 1999-07-13 |
| Model Number | 3300-001-000 |
| Catalog Number | N/ |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 224755 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 E. MILHAM AVE. KALAMAZOO MI 49001 US |
| Baseline Brand Name | KNIFELIGHT |
| Baseline Generic Name | KNIFE, SURGICAL LAMP, SURGICAL |
| Baseline Model No | 3300-001-000 |
| Baseline Catalog No | NA |
| Baseline ID | 3300-001-000 |
| Baseline Device Family | KNIFELIGHT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961122 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-07-13 |