MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for TABLE, CYSTOMETRIC, ELECTRIC manufactured by .
[145621867]
Following scheduled cystoscopy and right ureteral stent insertion by surgeon, patient was repositioned from lithotomy to supine position on the table. The technician stated he was having difficulty with correct positioning of the table for the extracorporeal shockwave lithotripsy (eswl) part of the procedure. He contacted his company and attempted twice to recalibrate the machine/ table, but it still was not responding correct. The surgeon, charge nurse, and or manager were notified. This part of the procedure was cancelled, and patient was transported to pacu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8627173 |
| MDR Report Key | 8627173 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-04-24 |
| Report Date | 2019-04-12 |
| Date Reported to FDA | 2019-04-12 |
| Date Reported to Mfgr | 2019-05-21 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Generic Name | TABLE, CYSTOMETRIC, ELECTRIC |
| Product Code | MMZ |
| Date Received | 2019-05-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-20 |