MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-03-26 for CELLIENT 71663-001 manufactured by Cytyc Corp..
[20238633]
Customer was not satisfied with cellularity of cellient blocks with known tumor. Upon discussion, the physician pointed out his concerns and disappointment with our equipment. He said that when he has a sample with a lot of material he has problems in obtaining good results with cellient. He also expressed concern because usually the type of pts that come with this sample are the ones with a had clinical picture meaning that the probability of finding cancer is extremely high. He said that our filter did not have the capability to process enough material to make him comfortable or make a diagnosis on any pt that has a serious tumor. He ran a cell block through cellient on different occasions and then used the remainder of the material to run a normal cell block. The results are better using the normal procedure rather than when using cellient. He feels that the cellient equipment is great for thyroid fna or for any applications that have little material on it. The sample he ran on the equipment was liquid. He also showed three to five slides prepared on cellient where the sample tissue after the process did not come as a full circle on the slide. It has less than a full circular formation and others look like a half moon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2008-00033 |
| MDR Report Key | 1019630 |
| Report Source | 06 |
| Date Received | 2008-03-26 |
| Date of Report | 2008-03-26 |
| Date of Event | 2008-02-28 |
| Date Mfgr Received | 2008-02-28 |
| Date Added to Maude | 2008-07-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RAJ KASBEKAR, MGR |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638858 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLIENT |
| Generic Name | CELLIENT |
| Product Code | KET |
| Date Received | 2008-03-26 |
| Model Number | 71663-001 |
| Catalog Number | NI |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1018680 |
| Manufacturer | CYTYC CORP. |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-03-26 |