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

Catalog Number 50004

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/01/2015

Event Type  malfunction  

Manufacturer Narrative

Ni.

Event Description

A customer reported a boston scientific clip was found in their olympus endoscope after it was reprocessed in an evotech endoscopic cleaner and reprocessor (ecr).The scope was used on a patient before the clip was discovered.It is unknown how long the clip had been there.The evotech ecr completed the cycle.The hospital's pre-cleaning steps are not known at this time.There is no reported patient injury or infection at this time.However, advanced sterilization products (asp) has determined that this situation could present a potential risk of infection and has decided to report this event.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included a review of the device history record (dhr), service history record, trending of the product malfunction code and system risk analysis (sra).The dhr was reviewed and the unit met manufacturer specifications at the time of release.No issues were related to this failure mode.The service history for the past six months was reviewed from 3/7/2015 to 9/3/2015 and trending was not exceeded.Trending analysis for the product malfunction code of ''procedure related" was reviewed from october 2014 through september 2015 and there was no significant trend was observed.The sra was reviewed for the issue of "procedure related" and the risk was determined to be low.The clip was reported to be less then 1/4 to 1/2 inch in size but small enough to pass flow parameters.Thus, high-level disinfection was achieved and the cycle completed and met functionality.No injuries were reported.The cause of the issue was determined to be user error.The customer stated they follow the recommended bedside pre-cleaning according to the scope manufacturers instructions for use (ifu), but they did not follow the evotech® ecr user guide which states to check and remove all stents/clips in the scope prior placing into the evotech® ecr.The user guide further states, "these instructions, based on the sgna guidelines, are not intended to replace the instructions provided by the manufacturers of the endoscopes, but are to be used in conjunction with them." the customer was provided additional training and education on proper bedside cleaning prior to placing in the evotech® ecr.In addition, the customer has been since modified their pre-cleaning procedure to include brushing of the scope and checking for stents and clips.The issue will be tracked and trended.No further investigation is necessary at this time.

• 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: 5112171
• MDR Text Key: 27060841
• Report Number: 2084725-2015-00414
• 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: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: N/A
• Other Device ID Number: 50004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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