MAUDE Adverse Event Report: RUHOF DISPOSABLE ENDOSCOPE VALVES SET; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Lot Number 4219

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2018

Event Type  malfunction  

Event Description

Disposable valve used on endoscope broke when taken out of package.

• Brand Name: DISPOSABLE ENDOSCOPE VALVES SET
• Type of Device: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): RUHOF
• MDR Report Key: 7227950
• MDR Text Key: 98680452
• Report Number: MW5074961
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2022
• Device Lot Number: 4219
• Other Device ID Number: REF 3455VXO
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1