MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-07-12 for JAKO-KLEINSASSER MICRO-LARYNGEAL SCISSORS * 50-6479 manufactured by *.
[381400]
A small piece of the scissor's blade detached from the instrument during a micro direct laryngoscopy procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515651-2004-00043 |
| MDR Report Key | 611365 |
| Report Source | 06 |
| Date Received | 2004-07-12 |
| Date of Report | 2004-06-11 |
| Report Date | 2004-06-11 |
| Date Mfgr Received | 2004-06-11 |
| Date Added to Maude | 2005-06-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BRADLEY SEIDEN, MGR. |
| Manufacturer Street | 200 PRECISION RD. STE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2154428892 |
| Manufacturer G1 | PILLING SURGICAL |
| Manufacturer Street | 200 PRECISION RD. STE 200 |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19044 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAKO-KLEINSASSER MICRO-LARYNGEAL SCISSORS |
| Generic Name | MICRO-LARYNGEAL SCISSORS |
| Product Code | KBM |
| Date Received | 2004-07-12 |
| Model Number | * |
| Catalog Number | 50-6479 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 601161 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Baseline Brand Name | JAKO SCISSORS |
| Baseline Generic Name | LARYNGEAL SCISSOR |
| Baseline Model No | 50-6479 |
| Baseline Catalog No | 50-6479 |
| Baseline Device Family | MICRO LARYNGEAL SCISSORS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-07-12 |