MAUDE Adverse Event Report: MEDIVATORS INC. ENDOGATOR; ENDOSCOPE AND/OR ACCESSORIES

Model Number EGP-100

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 07/20/2015

Event Type  malfunction  

Event Description

Scope irrigator pedal malfunctioned and flattened and was unusable during procedure.Pedal should be inflated to work properly.Equipment had to be manipulated multiple times during procedure to get it to work properly.Clinical engineering evaluated equipment failure and determined that the pedal was worn out.A new pedal ordered.
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manufacturer response for endoscope irrigator pedal, scope irrigator pedal (per site reporter)
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contacted customer service at medivators.The customer service staff indicated they do not need the malfunctioning equipment returned.This is an issue which is remedied by purchasing new pedals.Age of equipment is unknown.Feel it was due to be replaced anyway.

• Brand Name: ENDOGATOR
• Type of Device: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th avenue north; minneapolis MN 55447
• MDR Report Key: 4972514
• MDR Text Key: 6338652
• Report Number: 4972514
• Device Sequence Number: 1
• Product Code: OCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: EGP-100
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2015
• Event Location: Other
• Date Report to Manufacturer: 08/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 53 YR
• Patient Weight: 109