MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for CLEARIFY VISUALIZATION SYSTEM 21-345 manufactured by Covidien Llc.
[146705701]
During a robotic assisted laparoscopic biopsy and fulguration of endometriosis, partial left ovarian cystectomy, right ovarian cyst draining and complete left ureterolysis, visualization system failed to ever turn on. It is believed that the battery it came with failed. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086989 |
| MDR Report Key | 8654927 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-23 |
| Date Added to Maude | 2019-05-30 |
| 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 | RISK MANAGER |
| 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 | CLEARIFY VISUALIZATION SYSTEM |
| Generic Name | ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY |
| Product Code | OCT |
| Date Received | 2019-05-29 |
| Model Number | 21-345 |
| Catalog Number | 21-345 |
| Lot Number | D8M0072Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-29 |