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

Catalog Number	0620050000
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that medical intervention was performed to prevent the patient from coding.
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 ¿insufflating the abdomen the patients n title volume started to drop.¿ was not confirmed.According to wom: visual inspection: the device was received on dec 3, 2024 for evaluation.The device was shipped with the correct packaging (packaging arrived damaged).The unit is in bad cosmetic condition; the upper casing has some scratches, the lower casing is dented, the front panel has some scratches and the silicon tube at exhaust port is damaged.Functional inspection: functional inspection indicated the returned device passed all criteria.This included a flow and pressure 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#0620050000 rev yb, 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.Most probable root cause is seen as suspected too quick insufflation with potentially not optimized ventilation setting or/and potential low co2 tolerance of the patient or/end insufflation not in the pneumoperitoneum.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that medical intervention was performed to prevent the patient from coding.

• Brand Name: PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM
• 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: 20678806
• Report Number: 0002936485-2024-00790
• Device Sequence Number: 15261420
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 0620050000
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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: Male