STORZ *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-10 for STORZ * manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[486307] Female patient undergoing a diagnostic hysteroscopy, diagnostic laparoscopy, attempted hysteroscopic resection of submucous fibroids for menorrhagia and uterine fibroids. A diagnostic hysteroscope was introduced under camera guidance and saline used as the distending medium. In anticipation of using of a resectoscope via the hysteroscope, diagnostic laparoscopy was performed for safety reasons. The nageotte instrument was used to aspirate the small amount of saline already present within the abdomen. The ancillary operating room staff indicated that they were uncertain as to the volume yielded via the nageotte with respect to its contribution to the intake and output monitoring machine. Surgeon asked for complete assessment visually with respect to intake and outputs since the data from the machine did not appear credible. The operating room staff was able to account for approximately 1400 ml. Of liquid extracted via hysteroscope setup, as well as the laparoscope. Given the degree of imbalance, the surgeon immediately terminated the procedure, and advised the anesthesiologist that, we may be developing a condition of fluid overload. In anticipation of potential complication such as hyponatremia, the surgeon consulted another physician for help in managing electrolyte imbalance. Anesthesia provided the patient with a small dose of intravenous lasix. Patient was taken out of trendelenburg positioning and her abdominal incisions were closed. Prompt and impressive diuresis began. The patient's airway was inspected to make sure that there was no significant surrounding edema and she was safely extubated. Patient was taken to the recovery room where her vital signs continued to be normal and excellent urine output continued. The bmp (basic metabolic panel - electrolyte blood test) returned indicating that her sodium was 112 with a decrease in chloride, but other electrolytes remained normal. Further discussions with consulting physician regarding electrolyte replacement, and it was decided to replace her urine output ml. Per ml. With normal saline. Surgeon spoke with consulting physician later that afternoon, and patient's sodium had already improved substantially. Surgeon elected to keep patient overnight for a repeat electrolyte evaluation, which returned to normal limit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number722956
MDR Report Key722956
Date Received2006-05-10
Date of Report2006-05-10
Date of Event2006-04-25
Report Date2006-05-10
Date Reported to FDA2006-05-10
Date Added to Maude2006-06-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTORZ
Generic NameFLUID MANAGEMENT SYSTEM
Product CodeLTA
Date Received2006-05-10
Returned To Mfg2006-05-09
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key712029
ManufacturerKARL STORZ ENDOSCOPY-AMERICA, INC.
Manufacturer Address600 CORPORATE POINTE CULVER CITY CA 902307600 US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-05-10

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