MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-29 for FLEXIBLE VIDEO CYSTOSCOPE 11272VNU manufactured by Karl Storz Endovision.
[53438129]
The product evaluation concluded the following: shaft has over bends next to strain relief. Monocoil to vertebrae welding break. Multiple scrape marks inside channel with bump, no leak found. Voids around spread lens and ccd window with debris. Chipped spread lens. Debris at handle housing and at hand grip surface. Kinked umbilical cord. Broken light fibers inside handle housing and at vertebrae system. Debris at angle cover surface. The evidence produced from this investigation suggests that user error can be linked to the physical state of the instrument. The documented scope damage could be a contributory factor towards patient infection. In order to perform a microbiological assessment of the video cysto urethroscope (11272vnu, s/n (b)(4)), it was sampled by flushing all channels and the outer surfaces with process water. The samples were submitted to (b)(4) laboratories to specifically determine if p. Aeruginosa was present. The final report from (b)(4) laboratories confirmed that the organism in question (p. Aeruginosa) was not present in the samples analyzed.
Patient Sequence No: 1, Text Type: N, H10
[53438130]
Allegedly, the doctor performed a cystoscopy procedure on a patient. Post procedure, the patient went to the er and was found to have dysuria. Urine culture of patient confirmed pseudomonas aeruginosa infection. He was treated with a ceftazidine iv and is responding well to antibiotics. There were 3 patients infected; this report is for patient #1.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221826-2016-00127 |
| MDR Report Key | 5912719 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-29 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-06-06 |
| Date Mfgr Received | 2016-07-29 |
| Device Manufacturer Date | 2012-12-20 |
| Date Added to Maude | 2016-08-29 |
| 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 |
| 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 | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| 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 | 2016-08-29 |
| Returned To Mfg | 2016-08-11 |
| Model Number | 11272VNU |
| Catalog Number | 11272VNU |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2016-08-29 |