MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS); INSUFFLATOR, LAPAROSCOPIC

Model Number FM300

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).Additional information will be provided once the investigation has been completed.

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 jul 3, 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 2020-07-31.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 sood j.Advancing frontiers in anaesthesiology with laparoscopy.World j gastroenterol wjg.2014 oct 21 ;20(39):14308-14.121 park ey, kwon j-y, kim kj.Carbon dioxide embolism during laparoscopic surgery.Yonsel med j.2012 may;53(3):459- 66.131 oeguara c, davis c.Laparoscopic entry techniques.Curr opin obstet gynecol.2011 aug;23(4):268-72.The incident occurred in canada and the preliminary problem report was submitted to health cananda on 26 june 2020.The final report was submitted on 07 august 2020.Stryker has reported the casas also to the fda (mdr 0002936485-2020-00243) on 25 june 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.

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.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (AMERICAS)
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10195720
• MDR Text Key: 196475636
• Report Number: 0002936485-2020-00243
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (y/n): N
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• 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

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 32 YR