MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for MANOSCAN AR 3D PROBE (AND RECTAL CATHETER) AR 3D CATHETER MSC-3885-3D manufactured by Given Imaging / Medtronic.
[127855318]
Manoscan ar rectal probe catheter model #msc-3885-3d. Mfr's reprocessing instructions are not current with va standards and current regulatory standards (e. G. , on precleaning or pre-treatment instructions; calibration of probe ifu's, disposable sheath that attaches "use disinfectant wipe, talc," this then goes into pt. If sheath is compromised the item will potentially backflow with pt body fluids through the lumen and potentially leach to the next pt due to improper cleaning if the lacking ifu is followed. Ifu states soaking ubt no bruising or manual cleaning of lumen, improper storage (luer lock holder that could harbor moisture in the lumen as it blocks the very small channel), plastic storage box does not have any instructions how to clean or high level disinfect, is not vented for the channels to have a continuous air flow). 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 | MW5081373 |
| MDR Report Key | 8078475 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 AR 3D PROBE (AND RECTAL CATHETER) |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-11-15 |
| Model Number | AR 3D CATHETER MSC-3885-3D |
| 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 | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |