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.
[105118578]
Scope was evaluated. We found there was a scrape in the working channel, but no leak. Investigation still in progress.
Patient Sequence No: 1, Text Type: N, H10
[105118579]
Allegedly, the physician performed a cystoscopy procedure on patient. Post the procedure, patient was admitted to the icu. Patient's urine was cultured which confirmed pseudomonas aeruginosa infection. Patient was treated by an outside doctor. The clinic does not have any information on treatment, but most likely the patient received antibiotics.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2018-00029 |
| MDR Report Key | 7418170 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-10 |
| Date of Report | 2018-03-19 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-03-19 |
| Device Manufacturer Date | 2017-01-31 |
| 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 |