MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for MANOSCAN ANAL RECTAL CATHETER MSC-2192 manufactured by Given Imaging / Medtronic.
[127855924]
Manoscan ar rectal catheter model# 2192. Mfr's reprocessing instructions are not current with va standards and current regulatory standards are not up to date (e. G. , on precleaning or pre-treatment instructions, use of dental floss to tie a balloon off on the sheath, which is one time use, then goes into pt, soaking but no brushing / manual cleaning of lumen, improper storage). The company has been contacted and won't provide anything more/further clarification. Also, irrigation catheter that runs through the catheter and appears to be disposable, however, it is not and is impossible for it to be cleaned appropriately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081374 |
| MDR Report Key | 8078506 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-13 |
| Date Added to Maude | 2018-11-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MANOSCAN ANAL RECTAL CATHETER |
| Generic Name | SYSTEM, GASTROINTESTINALK MOTILITY ELECTRICAL |
| Product Code | FFX |
| Date Received | 2018-11-15 |
| Model Number | MSC-2192 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING / MEDTRONIC |
| Manufacturer Address | LOUISVILLE KY 40206 US 40206 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |