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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORP. STRYKER LAPAROSCOPIC TOWER; INSUFFLATOR, LAPAROSCOPIC
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STRYKER CORP. STRYKER LAPAROSCOPIC TOWER; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Device Problems Mechanical Problem (1384); Improper Flow or Infusion (2954)
Patient Problem Insufficient Information (4580)
Event Date 05/19/2020
Event Type  malfunction  
Event Description
Insufflation on stryker laparoscopic tower was not regulating properly.Insufflation gas tanks were replaced three times throughout the surgery due to alert prompts by the insufflator machine; however it was evident that each tank that was removed/replaced still had gas leftover inside.As a result, patient's intra-thoracic pressure fluctuated throughout surgical procedure.We could not find any reason why the gas would have run out as fast as the staff said it did.Clinical engineering contacted stryker- representative switched out the device with a loaner and it was installed on tower.Requested service report when evaluation/repair is completed.Device still out for repair.
 
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Brand Name
STRYKER LAPAROSCOPIC TOWER
Type of Device
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
STRYKER CORP.
5900 optical ct
san jose CA 95138
MDR Report Key12057747
MDR Text Key258086494
Report Number12057747
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2021
Event Location Hospital
Date Report to Manufacturer06/24/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age26645 DA
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