MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for TOMCAT INSTRUMENT ASY-07379 manufactured by Hologic, Inc..
[120693629]
A customer complained that after their thinprep vials were finished processing by the tomcat instrument, the returned vials were recapped too tight. This caused their cytologists to experience pain in their wrists when uncapping the vials. One cytotech has asked for medical attention and been diagnosed with carpal tunnel syndrome that could be attributed with uncapping these vials. Per risk assessment, the severity of this risk is serious where tightly capped thinprep vials could have resulted in a customer seeking medical intervention and being diagnosed with carpal tunnel syndrome. However, the probability of harm is remote as being diagnosed with carpal tunnel syndrome while just uncapping thinprep vials is unlikely but possible to occur over the lifetime of the product. Further investigation into this issue is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2018-00010 |
| MDR Report Key | 7887349 |
| Date Received | 2018-09-18 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-08-23 |
| Date Added to Maude | 2018-09-18 |
| 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 | MS. JULIETTE BUSSE |
| Manufacturer Street | 10210 GENETIC CENTER DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DR. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TOMCAT INSTRUMENT |
| Generic Name | SAMPLE TRANSFER SYSTEM |
| Product Code | JQW |
| Date Received | 2018-09-18 |
| Catalog Number | ASY-07379 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 10210 GENETIC CENTER DR SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-18 |