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

Catalog Number	0620050000
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 developed subcu crepitus and had to remain intubated and sent to the icu.In icu for less than 24hours and was discharged.
Additional Manufacturer Narrative
This device was received at oem-wom for evaluation.Based on the oem-wom investigation report the reported failure ¿patient developed subcu crepitus¿ was not confirmed.According to wom: visual inspection: the device was received on may 7, 2025, for evaluation.Unit was shipped with the correct packaging (packaging was damaged), device in fair cosmetic condition, the filter holder is missing, and the front panel is chipped.Functional inspection: functional inspection indicated the returned device passed all criteria.This included a occlusion test, overpressure test, venting valve test 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 ya, sn (b)(6) is working according to specification.Probable root cause: most of the reasons for occurrence of a subcutaneous emphysema/ crepitus are related to surgical technique and trocar placement.Incorrect placement of a cannula, veress needle or a trocar into subcutaneous tissue may lead to emphysema, which can lead to crepitus.A big leakage of co2 around trocar incisions may also lead to subcutaneous emphysema.Other risk factors are prolonged surgeries, the use of many access points to the abdominal cavity and elevated abdominal pressure.The device was returned for evaluation, and as per evaluation results the unit was found to be functioning per specifications.In addition, the event description does not include any indication for a device malfunction, nor is subcutaneous emphysema/crepitus considered a serious injury.Hence this case is considered as not reportable.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the patient developed subcu crepitus and had to remain intubated and sent to the icu.In icu for less than 24 hours and was discharged.

• 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: 21998016
• Report Number: 0002936485-2025-00436
• Device Sequence Number: 9530576
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: 04056702001308
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/14/2025

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
• Date Returned to Manufacturer: 04/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 85 KG