MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-04-10 for FLEXIBLE VIDEO CYSTOSCOPE 11272VNU manufactured by Karl Storz Endovision.
[105141387]
The product evaluation concluded the following: there is debris on distal lens and distal tip of the scope, angle cover is cracked and has debris on it. The shaft marker rings are discolored. A nick was found on the handle housing. The evaluation results suggest that user error can be linked to the physical condition of the instrument. Investigation still in progress.
Patient Sequence No: 1, Text Type: N, H10
[105141388]
Allegedly, the physician performed a cystoscopy procedure on patient. Patient's urine was cultured and pseudomonas aeruginosa infection was confirmed from the lab results. Patient was treated with antibiotics from a doctor outside of the clinic. The doctor reported that patient is doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2018-00027 |
| MDR Report Key | 7418116 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-10 |
| Date of Report | 2018-03-12 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-03-12 |
| Device Manufacturer Date | 2011-01-11 |
| Date Added to Maude | 2018-04-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188100 |
| Manufacturer G1 | KARL STORZ ENDOVISION |
| Manufacturer Street | 91 CARPENTER HILL ROAD |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXIBLE VIDEO CYSTOSCOPE |
| Generic Name | FLEXIBLE VIDEO CYSTOSCOPE |
| Product Code | FBO |
| Date Received | 2018-04-10 |
| Returned To Mfg | 2018-04-02 |
| Model Number | 11272VNU |
| Catalog Number | 11272VNU |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | 91 CARPENTER HILL ROAD CHARLTON MA 01507 US 01507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-10 |