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

Catalog Number 50004

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Load not recalled.

Event Description

A customer reported a screen freeze issue with their evotech ecr and it is unknown if the load was reprocessed prior to being released for use on a patient(s).Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined that this situation presents a potential risk of infection.Asp recognizes that in many cases it would be difficult to trace infection back to the sterilization or high level disinfection.As a matter of policy asp has therefore decided to report cases of cancelled cycles if the complainant does not confirm that the load was reprocessed prior to use on a patient.

Manufacturer Narrative

Advanced sterilization products (asp) received additional information from the customer stating the involved load was reprocessed with the cycle cancellation issue.As a result, this complaint is deemed not reportable for unknown load status.

• 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: 5078102
• MDR Text Key: 25842783
• Report Number: 2084725-2015-00361
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50004
• Device Lot Number: 5041150137
• Other Device ID Number: 50004
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• 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