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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET; INSUFFLATOR, LAPAROSCOPIC

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STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Catalog Number 0620050250
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Death (1802); Embolism/Embolus (4438)
Event Date 06/15/2020
Event Type  Injury  
Manufacturer Narrative
Filing on behalf of the legal manufacturer, wom (world of medicine).The manufacture date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that patient passed away during medical procedure.Please note, at this time, it cannot be determined which, if any, of the reported devices may have caused or contributed to patient outcome.
 
Event Description
It was reported that patient passed away during medical procedure.Please note, at this time, it cannot be determined which, if any, of the reported devices may have caused or contributed to patient outcome.
 
Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿embolism, code blue, patient passed¿ was not confirmed.According to wom: visual inspection lnsufflator.The device was received on (b)(6) 2020 for evaluation.The upper casing had some dents and the holding plate inside the unit is slightly bent.The back of the device close to the gas inlet showed also some dents.Tube set the tube set was returned to wom on (b)(6) 2020.During previous visual inspection by stryker, damage to the tube set (scratches and cracks in the housing, dent in the tube) was found ta be due ta improper transport from the hospital to stryker.Functional inspection: lnsufflator.Functional inspection based on procedure test instruction v5.0 and its test on the test station tf300 according to aa243 indicated the returned device passed all criteria.This included the high flow, pressure sensors, occlusion and overpressure test with a result of each pass.Tube set readout of the rfid chip showed that the tubing set had such a short retention time in the insufflator that the transponder was not yet invalidated (the tube sets are invalidated 10 minutes of continuous use have elapsed after start is pressed the first time).Dimensional inspection: due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Reporting decision: the most possible root cause is assumed to be incorrect positioning of the veress needle leading to air embolism.Venous air embolism is the most rare but lethal complication in case of an accidental entry of gas into a blood vessel 111, and results in blockage of the right ventricle or pulmonary artery 121.Once an injury has occurred, the key to reduction in morbidity and mortality is early recognition and dealing with it effectively in the shortest time possible.111 (b)(6) advancing frontiers in anaesthesiology with laparoscopy.World j gastroenterol wjg.(b)(6) 2014.21 ;20(39):14308-14.121 (b)(6).Carbon dioxide embolism during laparoscopic surgery.(b)(6).(b)(6) 2012;53(3):459- 66.131 (b)(6).Laparoscopic entry techniques.Curr opin obstet gynecol.(b)(6) 2011;23(4):268-72.The incident occurred in canada and the preliminary problem report was submitted to health cananda on (b)(6) 2020.The final report was submitted on (b)(6) 2020.Stryker has reported the casas also to the fda (mdr 0002936485-2020-00243) on (b)(6) 2020.Stryker as sole distributor will assess and, if applicable, report in japan, argentina, columbia, south korea, and the philippines.Summary: the reported incident could not be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.The information obtained does not reasonably suggest that device has or may have caused or contributed to a death, serious injury or has malfunctioned in a manner that would be likely to cause or contribute to a death or serious injury if it were to recur.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
 
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Brand Name
PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET
Type of Device
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
MDR Report Key10195727
MDR Text Key196475665
Report Number0002936485-2020-00244
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04056702001490
UDI-Public04056702001490
Combination Product (y/n)N
PMA/PMN Number
K170784
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 09/21/2020
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 Health Professional
Device Catalogue Number0620050250
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/18/2020
Initial Date FDA Received06/25/2020
Supplement Dates Manufacturer Received06/18/2020
Supplement Dates FDA Received09/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age32 YR
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