MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-12-12 for THINPREP IMAGING SYSTEM, REVIEW SCOPE 70575-003 manufactured by Cytyc Corp..
[764295]
Event/problem: cytyc technical service received a call from cytology supervisor of labcorp. Supervisor stated, that one of the site's cytotechnologists (cts) had gone out on a recommended 3 week disability leave. The disability claims office contacted supervisor stating that cts reported extreme wrist and hand pain that was so severe, that she was unable to work and that the pain was due to discomfort from operating the review scope, a component of the thinprep imaging system. The disability claims office since has declared it a worker's compensation issue and has turned it over to that department. The results of that investigation or whether cts has since returned to work are currently unk. Supervisor stated, that labcorp policy mandates that all autoscans using the review scope be done using the manual start/stop method. Currently, the policy does not allow cts to use the auto start/stop or continuous autoscan, which are available features currently within the review scope operator's manual. Ms gagliardi also stated that cts are encouraged to do 140 slides per day, although it is not a requirement. Cytyc will further investigate this information during the device evaluation in order to determine if continuous manual start/stop or the encouraged number of slides per day could be considered contributing factors to the reported adverse event. Supervisor further stated, that this is not the first time cts has been on disability leave for wrist and hand pain and has had issues with one of her hands prior to using the review scope. It is unk which hand(s) were the subject or what the contributing factor of that disability claim entailed, but this is the first time cts has attributed her injury to operating the review scope.
Patient Sequence No: 1, Text Type: D, B5
[8034970]
It is unk which review scope was operated by cts. As part of the device evaluation, the exact serial number of the review scope subject of this medical device report will be identified and reported via a mdr supplemental report. Device evaluation: cytyc corp will conduct a full investigation and evaluate the review scope operated by cts in order to determine whether the review scope caused or contributed to this adverse event. The results of that investigation will be submitted via a mdr supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2007-00052 |
| MDR Report Key | 966300 |
| Report Source | 05,06 |
| Date Received | 2007-12-12 |
| Date of Report | 2007-12-10 |
| Date of Event | 2007-11-12 |
| Date Mfgr Received | 2007-11-12 |
| Date Added to Maude | 2007-12-26 |
| 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 | LISA LACROIX, SR SPECIALIST |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638854 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THINPREP IMAGING SYSTEM, REVIEW SCOPE |
| Generic Name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
| Product Code | KEW |
| Date Received | 2007-12-12 |
| Model Number | 70575-003 |
| Catalog Number | 70575-003 |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 937892 |
| Manufacturer | CYTYC CORP. |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-12-12 |