ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,05 report with the FDA on 2009-12-10 for ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER 20301 manufactured by Minntech Corp..

Event Text Entries

[8924047] Asp investigation summary: the investigation included a service history review, complaint trending by problem code, failure mode and effects analysis, system hazard and user misuse analysis and health hazard evaluation. The dhr for this aer unit was not reviewed as the root cause was determined to be use error and not manufacturing related. Within the past six months ((b)(4) 2009 - (b)(4) 2009), this unit, per account history, does not show any similar issues due to incorrectly setting the disinfect time on the aer unit. Thus, there is not a significant trend. A review of the complaint history for aer units with problem code "e09-disfectant time not entered" did not reveal a significant trend over the past 12 months ((b)(4) 2009 - (b)(4) 2010). An assessment of the aer fmea (failure mode and effects analysis) revealed the rpn (risk priority number) for high level disinfect cycle time related failure mode is below the threshold of 100, indicating that the associated risk is minimal. An assessment of the cidex opa solution fmea (failure mode and effects analysis) revealed the rpn (risk priority number) for insufficient exposure time is below the threshold of 100, indicating that the associated risk is minimal. The cidex opa solution/disopa shuma (system hazard and user misuse analysis) was reviewed and it was determined that the risk due to improper soaking is a category ii - alarp (as low as reasonably practicable). The hhe (health hazard evaluation) was reviewed for similar issues of a shorter disinfect time on the aer and the hazard/risk index was 6, which indicates the associated risk is low. The root cause was determined to be use error of incorrectly setting the disinfect time on the aer unit. Upon follow-up, the customer stated that the aer was no longer in service. The customer refused to provide any further information. A letter was sent to the customer recommending they review the ifu (instructions for use) for their disinfectant of choice and to follow all directions for use.
Patient Sequence No: 1, Text Type: N, H10


[20923354] The customer alleged the disinfect cycle time on the aer unit was set at one minute and the wash cycle was set at five minutes. It was documented. Asp informed the customer the aer unit with the heater requires a disinfect time of five minutes. It was reported that the customer used this setting since 2008. The customer does not know when in 2008 or how many scopes were processed. It was reported that facility's biomedical engineer believed the heater lamp was off. Asp advised the customer to reset the unit to a minimum of one minute wash and to reset the disinfect time to five minutes since the unit is equipped with a heater. An asp clinical education consultant (cec) contacted the customer and followed up with the issue.
Patient Sequence No: 1, Text Type: D, B5


[21200263] (b)(4) - disinfect time. All related mdrs: 2150060-2009-00173 and 2150060-2009-00174.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2150060-2009-00174
MDR Report Key1575471
Report Source*,05
Date Received2009-12-10
Date of Report2009-11-12
Date of Event2009-11-12
Date Mfgr Received2011-01-07
Date Added to Maude2011-01-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactGINNY STAMBERGER
Manufacturer Street33 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 96218
Manufacturer CountryUS
Manufacturer Postal96218
Manufacturer Phone9497893837
Manufacturer G1MINNTECH CORP.
Manufacturer Street14605 28TH AVE NORTH
Manufacturer CityMINNEAPOLIS MN 55447
Manufacturer CountryUS
Manufacturer Postal Code55447
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER
Generic NameAER EQUIPMENT
Product CodeNVE
Date Received2009-12-10
Model NumberNA
Catalog Number20301
Lot NumberNA
ID NumberPART #: NA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMINNTECH CORP.
Manufacturer AddressMINNEAPOLIS MN 55447 US 55447


Patients

Patient NumberTreatmentOutcomeDate
10 2009-12-10

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