MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Air Leak (1008); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 07/01/2015

Event Type  No Answer Provided  

Event Description

A facility using medivators advantage plus automated endoscope reprocessors reported that small blisters/bubbles filled with clear liquid developed on the sheaths of their pentax ec-3890li endoscopes.It is unknown what the clear liquid is or if the pentax endoscopes were used on patients.In the event that the bubbles/blisters ruptured during a procedure, being the composition of the clear liquid is unknown, there is potential for patient cross-contamination or chemical colitis.

Manufacturer Narrative

A facility using medivators advantage plus automated endoscope reprocessors reported that small blisters/bubbles filled with clear liquid developed on the sheaths of their pentax ec-3890li endoscopes.It is unknown what the clear liquid is or if the pentax endoscopes were used on patients.In the event that the bubbles/blisters ruptured during a procedure, being the composition of the clear liquid is unknown, there is potential for patient cross-contamination or chemical colitis.During the fse visit, it was discovered that pentax only guarantees their scopes for 300-500 reprocessing cycles.The facility has reprocessed these scopes over 500 times.The pentax scopes have exceeded the pentax guaranteed life expectancy.It was also discovered that these scopes had been repaired with oem pentax sheaths.Medivators field service engineer (fse) visited the facility and checked the aer, which was operating according to specification.Medivators has data demonstrating that the advantage plus aer and rapicide pa high-level disinfectant are compatible with pentax endoscopes for 500 reprocessing cycles.To date, there have been no reports of patient illness or injury.This complaint will continue to be monitored within the medivators complaint handling system.

• Brand Name: MEDIVATORS ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447
• MDR Report Key: 4950615
• MDR Text Key: 6191516
• Report Number: 2150060-2015-00021
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Hospital Service Technician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 07/29/2015

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
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1