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

Catalog Number	0620050010
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was converted to an open procedure.
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.
Event or Problem Description
It was reported that the procedure was converted to an open procedure.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation, the reported failure ¿the message invalid tube set appeared¿ was not confirmed.According to wom: visual inspection: the device was received for evaluation.There are no indications of transport damage.The device was shipped with the correct packaging (packaging was damaged).The unit was found to be in poor condition, front panel is scratched, lower casing is dented by the front panel, filter is damaged, silicon tubing to rear air port ripped and the is taping on the ribbon cable to the display pcb.Functional inspection: functional indicated the returned device passed all criteria.This included a test of the tube set detection 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 y, sn (b)(6) is working according to specification.Probable root cause: the reported event could not be confirmed.There are no indications of a manufacturing issue.The event description is very poor.The end user did not respond to further enquiries.With this limited information the most probable root cause could not be determined.In the event description it was mentioned that "a kit" was used, and we only offer only a tube set.However, the conversion to open procedure would not lead to temporary or permanent serious deterioration of health.The reported failure mode will be monitored for future reoccurrence.

• 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; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20679036
• Report Number: 0002936485-2024-00791
• Device Sequence Number: 17962235
• Product Code: HIF
• UDI-Device Identifier: 04056702003456
• UDI-Public: 04056702003456
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2023
• 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