MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PNEUMOCLEAR + CO2 CONDG' INSUFFLATOR AM; Insufflator, Laparoscopic

Catalog Number	0620050000
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was during vein harvesting the unit collapsed the vein despite not having suction tubing.Staff also stated it's not keeping the vein insufflated properly.Since we had an issue with the insufflator tubing with some backflow.The pa decided to convert to open the arm to harvest the radial artery instead of doing it endoscopically.
Event or Problem Description
It was during vein harvesting the unit collapsed the vein despite not having suction tubing.Staff also stated it's not keeping the vein insufflated properly.Since we had an issue with the insufflator tubing with some backflow.The pa decided to convert to open the arm to harvest the radial artery instead of doing it endoscopically.

• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 25725562
• Report Number: 0002936485-2026-00448
• Device Sequence Number: 9385070
• Product Code: HIF
• UDI-Device Identifier: 04056702001308
• UDI-Public: (01)04056702001308(11)190603
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026
• Report Date (Section F): 07/06/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0620050000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2026
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2019
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 227 LB