MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-03 for CLEARVISION II, LENS IRRIGATION UNIT 40334120 manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[64045935]
The device was evaluated and we were unable to duplicate the issue. The unit was tested for about two hours, unit was working properly (never stopped working). Unit passed all functional, safety test. We recommended that the account send in their footswitch for evaluation to see if that device was the cause of the alarms.
Patient Sequence No: 1, Text Type: N, H10
[64045936]
Allegedly, during a nuero procedure a loud alarm sounded multiple times and the doctor also noted that the pump stopped irrigating. The doctor immediately replaced it with a manual pump and the doctor went on to complete the procedure. The hospital reported that there was no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2017-00001 |
| MDR Report Key | 6220495 |
| Date Received | 2017-01-03 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2016-11-30 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2017-01-03 |
| 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 | 0 |
| Brand Name | CLEARVISION II, LENS IRRIGATION UNIT |
| Generic Name | LENS IRRIGATION UNIT |
| Product Code | EJT |
| Date Received | 2017-01-03 |
| Returned To Mfg | 2016-12-13 |
| Model Number | 40334120 |
| Catalog Number | 40334120 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-03 |