MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for (GIVEN IMAGING) MANOSCAN ESO CATHETER ESO CATHETER MSC-3890-Z. manufactured by Given Imaging / Medtronic.
[127856158]
Manoscan esophageal catheter model #msc-3890-z. Mfr's reprocessing instructions are not current with va standards and current regulatory (e. G. , no precleaning or pre-treatment instructions; calibration of probe ifu's, disposable sheath that may or may not be used (contingent if it's for an impedance study-not-stated in ifu) attaches "use disinfectant wipe, talc," this then goes into pt. Ifu states soaking but no manual wiping or sponging to manual cleaning probe-this has several ridges on items, improper storage, plastic storage box does not have any instructions how to clean or high level disinfect, is not vented for continuous air flow). The company has been contacted and won't provide anything more/further clarification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081371 |
| MDR Report Key | 8078443 |
| 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 | (GIVEN IMAGING) MANOSCAN ESO CATHETER |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-11-15 |
| Model Number | ESO CATHETER MSC-3890-Z. |
| 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 |