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

Catalog Number 50004

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Test Result (2695)

Event Date 09/20/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the service history of the evotech¿ ecr shows preventative maintenance is up-to-date.The unit was last serviced on (b)(4) 2015 where the bacterial filters were replaced, and the unit was operating to specifications.The source of the mycobacteria is unknown at this time.There have been no reported patient serious injuries or infections.The patients continue to be monitored by infectious disease and pulmonary specialists.No medications to date have been given to treat the bacteria.There is no evidence of a device malfunction and no patient serious injury or infection.However, since the source of the bacteria is still unknown and the customer used a non-validated high level disinfectant in the evotech¿ ecr, advanced sterilization products (asp) has decided to report this event due to an overabundance of caution.This is four of twelve 3500a reports being submitted for this event.Please reference manufacturer report numbers: 2084725-2015-00440, 2084725-2015-00441, 2084725-2015-00442, 2084725-2015-00443, 2084725-2015-00444, 2084725-2015-00445, 2084725-2015-00446, 2084725-2015-00447, 2084725-2015-00448, 2084725-2015-00449, 2084725-2015-00450, 2084725-2015-00451.

Event Description

A customer reported twelve (12) patients tested positive for atypical mycobacteria after undergoing bronchoscopy procedures.The flexible bronchoscopes used were cleaned and reprocessed in an evotech endoscopic cleaner and reprocessor (ecr).The facility's cleaning methods included pre-cleaning and soaking of scopes with prolystica enzymatic presoak and cleaner and municipal water that includes a (b)(4) single-use water filter on the faucet.It was noted that metricide pa plus cleaner was used in the evotech ecr which is not a validated high level disinfectant for the evotech ecr.The facility conducted the following tests and the results are listed below: patient cultures were taken from the pulmonary fluid and subtypes were confirmed by a dna probe.The bronchoscopes used on the patients were found to be negative for the mycobacteria.Bacterial filters from the evotech ecr tested positive for the bacteria confirming the filters are operating properly.

Manufacturer Narrative

Upon further follow-up with the customer, it was determined that metricide¿ opa was not used in the evotech¿ ecr as initially indicated.The customer stated only cidex¿ opa solution is used in their evotech¿ ecr and metricide¿ opa is used only for manual cleaning of their instruments.(b)(4).Method: sterility method verification.Result: no failure detected.Conclusion: unable to confirm complaint.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 4/2/2015 to 9/29/2015 and trending was not exceeded.Trending analysis for the product malfunction code of ''load not recalled" was reviewed from october 2014 through september 2015 and no significant trend was observed.The sra was reviewed for the issue of "load not recalled" with "quality problem with no impact to safety" and the risk was determined to be low.No problem could be found in regards to the functionality of the evotech¿ ecr.The customer's procedures for scope processing were observed and found to be followed appropriately.It was noted the customer was not changing out the micron filters in their water filtration system and have been advised to do so on a regular basis.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: 5155156
• MDR Text Key: 28741955
• Report Number: 2084725-2015-00443
• 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: 09/22/2015

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
• 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: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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