MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG EQUIMAT SYSTEM

Model Number 20302020-1

Device Problem Volume Accuracy Problem (1675)

Patient Problem Edema (1820)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

The hospital is not returning the fluid management system at this time.They did report that their biomed tested the unit after the procedure and found it to function well.They retained the devices, but not the containment cannisters; they had reported a large volume of fluid on the floor, but could not confirm that there was damage to the containers because they were scrapped.

Event Description

Allegedly, during a diagnostic hysterscopy and myomectomy, the or personnel noticed they were not getting accurate deficit readings.They paused procedure and zeroed out system, recalibrated, and checked all connections and found to be good; no leaks found.They then hung 6 new bags containing 3 liters of saline each.They still continued to get inaccurate readings and monitored deficit manually.Later they noticed patient body temperature had dropped and blood pressure, heart rate and respiratory rate was increasing.They wrapped warm blankets around patient's head and intubated patient.At that time the doctor had completed 90% resection of the myomas and due to patient's condition at the time she stopped the procedure.Doctor stated that the myomectomy she had performed was sufficient; no further procedure is scheduled for this patient.Patient was sent to icu; pulmonary edema was not confirmed but they suspected an intravascular volume overload.They placed an arterial line into the patient and monitored for 2 days; the next day they extubated patient and the following day she was discharged in good condition.

Manufacturer Narrative

We sent our clinical product performance liaison to the hospital to evaluate the fluid management system.Here are the results: "all tests performed on the equimat were recorded as a pass.No failures existed.The weighing cell was inspected for any physical damage to the hook assembly, and none was noted.The equimat and weighing cell were tested for consistent measurement several times by hanging a 500 gram weight on the hook, and then removing.Each time the measurement was consistent without failure.Based on the test results, it appears that all of the karl storz devices are functioning correctly.Proper function of all safety alarms and safeguards were confirmed." the evaluation also included a possible cause for the event reported: "one observation noted during the inspection of the cart was the collection containers.During testing, intermittently the containers were not holding pressure correctly.This will cause intermittent performance regarding solution removal or possible deficit calculation." hospital was advised to be certain that when installing the cap that it is properly secured so no leaks exist.

Event Description

Allegedly, during a diagnostic hysteroscopy and myomectomy, the or personnel noticed they were not getting accurate deficit readings.They paused procedure and zeroed out system, recalibrated, and checked all connections and found to be good; no leaks found.They then hung 6 new bags containing 3 liters of saline each.They still continued to get inaccurate readings and monitored deficit manually.Later they noticed patient body temperature had dropped and blood pressure, heart rate and respiratory rate was increasing.They wrapped warm blankets around patient's head and intubated patient.At that time the doctor had completed 90% resection of the myomas and due to patient's condition at the time she stopped the procedure.Doctor stated that the myomectomy she had performed was sufficient; no further procedure is scheduled for this patient.Patient was sent to icu; pulmonary edema was not confirmed but they suspected an intravascular volume overload.They placed an arterial line into the patient and monitored for 2 days; the next day they extubated patient and the following day she was discharged in good condition.

• Brand Name: EQUIMAT SYSTEM
• Type of Device: EQUIMAT SYSTEM
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; mittlestrasse 8; 78503; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittlestrasse 8; 78503; tuttlingen ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-8519 ; 4242188201
• MDR Report Key: 5193071
• MDR Text Key: 30014600
• Report Number: 9610617-2015-00089
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20302020-1
• Device Catalogue Number: 20302020-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2015
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization