MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR + CO2 CONDG INSUFFLATOR GLB; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620050010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced bradycardia requiring cpr and conversion procedure was converted to open surgery.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.Stryker is the initial importer of this product.The legal manufacturer is world of medicine (wom).Wom has been made aware of this report event.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation, the reported failure ¿patient experiencing bradycardia requiring cpr and conversion to open surgery.¿ was not confirmed to have issues with the insufflator.According to wom: visual inspection the device was received on (b)(6) 2025 for evaluation.There are no indications of transport damage.Unit was shipped with the correct packaging (packaging damaged), device in fair cosmetic condition, the unit has a small stain on the right side of the front panel.Additionally, the upper casing is bent and the filter holder was damaged at the threading.Functional inspection functional inspection indicated the returned device passed all criteria.This included the pressure and flow test with a result of pass.Additionally, all safety features, including the occlusion test, overpressure test, venting valve test and suction flow safety threshold were passed.Dimensional inspection not possible because the device was not returned for evaluation.Investigation conclusion the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog#0620050010 rev y, 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.There are no signs of a manufacturing issue.The event description is very poor and general in nature.From a medical perspective: operating at a set pressure value for longer times 30 s) which is not tolerated by the patient even though it is within the settable pressure range, might lead to unwanted hemodynamic changes (e.G.Low heart rate).Setting the appropriate pressure, monitoring the patient and align communication with the anesthesiologist is in the responsibility of the operating team.There are other potential patients or procedure related contributing factors which could lead to low heart (bradycardia).However, there have been no reported evidence or claims that the device did not work according to its specifications or malfunctioned in any manner which could have contributed to bradycardia.Since there is no causal relationship between the associated device and the reported adverse event this case is considered as not reportable.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported the patient experienced bradycardia requiring cpr and conversion procedure was converted to open surgery.

• Brand Name: PNEUMOCLEAR + CO2 CONDG INSUFFLATOR GLB
• 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; burnaby; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21069322
• Report Number: 0002936485-2025-00010
• Device Sequence Number: 16991859
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Catalogue Number: 0620050010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 102 KG