MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR; EVOTECH EQUIPMENT

Catalog Number 50004

Device Problems Misconnection (1399); Use of Device Problem (1670)

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

Event Date 10/14/2015

Event Type  malfunction  

Event Description

A customer reported a processing error while using their evotech endoscopic cleaner and reprocesser (ecr), and it is unclear whether or not high level disinfection was achieved before releasing the scope for use on a patient.The customer stated that while preparing the bronchoscope bf-uc180f for cleaning and disinfecting in the evotech ecr, the user selected an incorrect model number (bf itq180) while entering the information into the ecr.The cycle ran and completed without incident.The unit did not cancel, and the printout stated high level disinfection was achieved.It wasn't until later the healthcare worker noticed on the printout that an incorrect model # was selected.There is no reported serious injury or adverse event related to this issue.The facility will continue to monitor the patient for potential infection.As a matter of policy, advanced sterilization products (asp) has decided to report this event since the scope was released and used on a patient and high level disinfection cannot be guaranteed.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), standards hazard list (shl).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.The shl shows the risk for biohazardous exposure to be limited.The assignable cause was user error.Follow-up with the facility confirmed there have been no reported patient infections.An asp clinical education consultant (cec) completed a customer training of the unit.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.

• Brand Name: EVOTECH¿ ENDOSCOPIC CLEANER AND REPROCESSOR
• Type of Device: EVOTECH EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618
• MDR Report Key: 5215562
• MDR Text Key: 30981909
• Report Number: 2084725-2015-00521
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50004
• Other Device ID Number: 50004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2011
• 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