MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. SINGLE SPIKE TUBE SET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	0250070530
Medical Device Problem Codes	Mechanical Problem (1384); Decrease in Pressure (1490)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported by the customer that the red button was not working properly on the tubing.Therefore there was a loss of insufflation.
Event or Problem Description
It was reported by the customer that the red button was not working properly on the tubing.Therefore there was a loss of insufflation.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received as the device was discarded, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: red button not working on tubing probable root cause: 1.Severe shipping conditions 2 material/design error 3.Damaged equipment 4.User error the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG. SINGLE SPIKE TUBE SET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22149440
• Report Number: 0002936485-2025-00512
• Device Sequence Number: 15406911
• Product Code: GEI
• UDI-Device Identifier: 37613327061353
• UDI-Public: 37613327061353
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K963646
• 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): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0250070530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown