MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-27 for TISSUE-TEK CRYO 2000 MICROTOME 4705 manufactured by Sakura Finetek U.s.a., Inc..
[169253]
User facility claims that they were unable to obtain usable frozen tissue sections (skin excisions) during a cancer pt's surgery to determined graft area. The pt's surgery was suspended and the margins were evaluated from paraffin sections. The pt then required add'l surgery for grafting. The user facility believes that the knife and/or knife holder was loosening from the cryostat microtome and they were obtaining alternating thick and thin section (unusable).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083544-2000-00002 |
| MDR Report Key | 301959 |
| Report Source | 05,06 |
| Date Received | 2000-10-27 |
| Date of Report | 2000-10-27 |
| Date of Event | 2000-09-28 |
| Date Mfgr Received | 2000-09-28 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2000-10-30 |
| 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 |
| Manufacturer Contact | MARSHA REID |
| Manufacturer Street | 1750 WEST 214TH ST |
| Manufacturer City | TORRANCE CA 90501 |
| Manufacturer Country | US |
| Manufacturer Postal | 90501 |
| Manufacturer Phone | 3109727800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSUE-TEK CRYO 2000 MICROTOME |
| Generic Name | MICROTOME, CRYOSTAT |
| Product Code | IDP |
| Date Received | 2000-10-27 |
| Returned To Mfg | 2000-10-10 |
| Model Number | 4705 |
| Catalog Number | 4705 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 292260 |
| Manufacturer | SAKURA FINETEK U.S.A., INC. |
| Manufacturer Address | 1750 WEST 214TH ST. TORRANCE CA 90501 US |
| Baseline Brand Name | TISSUE-TEK CRYO 2000 MICROTOME |
| Baseline Generic Name | MICROTOME, CRYOSTAT |
| Baseline Model No | 4705 |
| Baseline Catalog No | 4705 |
| Baseline ID | NA |
| Baseline Device Family | CRYO 2000 |
| 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. Other | 2000-10-27 |