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

Model Number	FM300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.Filling on behalf of world of medicine (wom).
Event or Problem Description
It was reported that the patient suffered cardiac arrest.Vital functions have been restored.
Additional Manufacturer Narrative
The device manufacture date is not known.This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿there was a cardiac arrest.According to medical personnel it was caused by the medical device¿ was not confirmed.According to wom: visual inspection; the device was received on jul 7, 2022 for evaluation.There are no indications of transport damage.The lower part of the housing was slightly bent and the sealing of the gas connection was missing.However, this would have no impact the device's operation.Functional inspection: functional inspection based on procedure test instruction for fm300 v7.0 indicated the returned device passed all criteria.This included a pressure test, flow measurement test, occlusion test & venting valve (vev) & overpressure test with a result of pass.Dimensional inspection: due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Investigation conclusion: the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog#0620050010 rev t, sn (b)(6) is working according to specification.Probable root cause: the reported event could be not confirmed.There are no indications of a manufacturing issue.The most probable root cause could not be determined.The device was returned to the manufacturer for investigation and full functional testing was conducted.The device was found to be working per specifications.Furthermore, the reporter provided additional information which also did not imply any causative correlation between a possible malfunction and the reported serious incident.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the patient suffered cardiac arrest.Vital functions have been restored.

• Brand Name: PNEUMOCLEAR PLUS CO2 CONDITIONING INSUFFLATOR (GLOBAL)
• Common Device Name: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14877701
• Report Number: 0002936485-2022-00390
• Device Sequence Number: 11260106
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K170784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: FM300
• Device Catalogue Number: 0620050010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown