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

Model Number 1-2-510.003

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

A medivators sales representative reported information about the facility performing a patient procedure and while using a reprocessed endoscope, a piece of human tissue fell out of the scope and into the patient.The tissue was obtained from the patient during the procedure using forceps and sent to the lab for analysis.The facility's biomed department evaluated the advantage plus automated endoscope reprocessor that was used to high level disinfect the scope.It was confirmed that it was performing within specification and there were no alarms or failures reported from the cycle.The facility then sent the scope back to olympus for inspection and it was reported that there was no damage in the scope channel that the tissue was removed from.In following up with the facility, the tissue was reported to be a piece of benign gastric tissue from another patient.The lab results reported nothing could have been transmitted to the patient.The facility informed the later patient of the incident and per the facility's policies, offered them screening services.At the time of following up with the facility, there was no report of patient harm related to cross-contamination or any additional medical attention being sought by the patient.While the facility claimed proper bedside pre-cleaning procedures were performed prior to reprocessing the scope in the aer, the facility is retraining on proper scope cleaning.Medivators field service department offered the facility a courtesy visit to evaluate the advantage aer but the facility declined.Medivators will continue monitoring this complaint within medivators complaint handling system.

Event Description

A medivators sales representative reported information regarding a patient procedure being performed at a facility involving human tissue falling out of a reprocessed scope and into the patient.The tissue was obtained during the procedure and analyzed in the facility's lab, determining that it was benign gastric tissue from another patient.The patient was informed of the cross-contamination incident and offered screening services by the facility.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 6902057
• MDR Text Key: 87748979
• Report Number: 2150060-2017-00042
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• 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: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1-2-510.003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• 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
• Patient Outcome(s): Other