MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PNEUMOCLEAR HTD HUMIDIF SMOKE EVAC TB ST; INSUFFLATOR, LAPAROSCOPIC

Catalog Number	0620050350
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was converted to 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.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: the insufflator shut down, asking us to ¿reconnect the tubing¿.Probable root cause: because device was not returned to oem - wom, probable root cause cannot be determined.The reported event could not be confirmed.There are no signs of a manufacturing issue.The event description is poor and general.Despite our follow-up attempts, no further information was received.There is only a "connect tube set" message, which is shown if there is no tube set connected (latching mechanism of tube set not engaged) and the insufflation is stopped.If the latching mechanism is not engaged during insufflation, either by accident or mechanical force the insufflation will stop and the "connect tube set" message will be shown.If the tube set is reconnected, insufflation can be continued by pushing the start button.With this limited information the most probable root cause could not be determined.It could be a device-independent is-sue or an actual malfunction.There was no report about a collapse of the pneumo with a potential danger of instrument to injure the patient.However, the conversion to open procedure would not lead to temporary or permanent serious deterioration of health.There is no serious injury reported.If, contrary to expectations, further information is still provided or the device is sent in for evaluation in the future, the reporting decision will be reassessed based on the investigation report.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the procedure was converted to open procedure.

• Brand Name: PNEUMOCLEAR HTD HUMIDIF SMOKE EVAC TB ST
• 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: 21201779
• Report Number: 0002936485-2025-00051
• Device Sequence Number: 7578113
• Product Code: HIF
• UDI-Device Identifier: 04056702001513
• UDI-Public: 04056702001513
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: 0620050350
• Device Lot Number: K23G173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Supplement Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown