MAUDE Adverse Event Report: RUHOF CORPORATION ENDOSCOPY KITS; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/03/2020

Event Type  malfunction  

Event Description

Two endoscopic scope kits arrived from the mfr, each containing a bug in addition to receiving 10-15+ kits that presented with black mold and dust debris.The manufacturer was notified.We were instructed that the problem had been corrected and received "newly" manufactured kits.Upon arrival to our facility, there were 7+ kits that continued to show mold and other debris.

• Brand Name: ENDOSCOPY KITS
• Type of Device: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): RUHOF CORPORATION
• MDR Report Key: 10436811
• MDR Text Key: 204044456
• Report Number: MW5096183
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/19/2020
• 24 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1