MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-17 for KARL STORZ 26602EQ 20302120 manufactured by Karl Storz Endoscopy America, Inc..
[18293958]
Patient with diagnosis of menorrhagia was undergoing a hysteroscopic resection of fibroid. The patient was brought into the operating room. Her cervix was visualized and sequentially dilated to allow the operative hysteroscope. The hysteroscope was introduced into the cavity. Deficit in the karl storz fluid management system was increasing throughout the case. When checking all the connections, the pole fell down that was holding the cannisters. This was felt to be the reason they were not getting accurate measurements. Using the morcellator device, the fibroid was removed. During the case, once it was determined that the karl storz fluid management system wasn't functioning properly, fluid was manually measured. When the deficit had reached 800 milliters of sodium chloride, the surgeon completed resecting. The instruments were removed. Good hemostatsis was noted. The patient was then transferred to recovery room in good condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4005040 |
| MDR Report Key | 4005040 |
| Date Received | 2014-07-17 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-04-09 |
| Report Date | 2014-07-17 |
| Date Reported to FDA | 2014-07-17 |
| Date Reported to Mfgr | 2014-08-13 |
| Date Added to Maude | 2014-08-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KARL STORZ |
| Generic Name | FLUID MANAGEMENT SYSTEM |
| Product Code | LTA |
| Date Received | 2014-07-17 |
| Model Number | 26602EQ |
| Catalog Number | 20302120 |
| Lot Number | * |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY AMERICA, INC. |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-17 |