MAUDE Adverse Event Report: SAKURA SEIKI CO., LTD. CHIKUMA FACTORY SKYTRON INTEGRITY 270; STEAM STERILIZER

Model Number	ASSR-AO12
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is a precautionary submission.There are no us marketed skytron integrity steam sterilizers with any similar incidents.The (b)(6) incidents were identified did not lead to any adverse events.Manufacturing preventative actions have been taken to strengthen the weld.The initial importer, skytron has reviewed the five skytron integrity steam sterilizers in the usa.
Event or Problem Description
The company became aware of two incidents outside of the usa with the steam sterilizer.The first incident was in (b)(6) 2017 and the second was (b)(6) 2017.A weld attaching the air heater/filter assembly to the main sterilizer unit showed signs of fatigue.The affected steam sterilizer model is only available in (b)(6), however the company's us model, skytron integrity 270, utilizes a similar air heater/filter assembly.The air heater/filter assembly supplies heated fresh air into the chamber after the sterilization and drying process has been completed.This allows the chamber to equalize to atmospheric pressure permitting the user to open the chamber and unload the units.If there is a failure to the weld, the chamber pressure would still equalize at the end of the sterilization and drying cycle, but the room air may not go through the filter.There has been no instances of fatigue or failure in the usa.

• Brand Name: SKYTRON INTEGRITY 270
• Common Device Name: STEAM STERILIZER
• Manufacturer (Section D): SAKURA SEIKI CO., LTD. CHIKUMA FACTORY; 46-1 shinden; chikuma, nagano 38700 18; JA 3870018
• MDR Report Key: 8591145
• Report Number: 3009685834-2019-00001
• Device Sequence Number: 16643764
• Product Code: FLE
• UDI-Device Identifier: 10841736100117
• UDI-Public: 10841736100117
• Combination Product (Y/N): N
• PMA/510(K) Number: K132439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment,Repair
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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
• Operator of Device: Health Professional
• Device Model Number: ASSR-AO12
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 05/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention