MAUDE Adverse Event Report: SAKURA SEIKI, CO., LTD. SKYTRON; INTEGRITY 270DD-RRSR

Model Number	G-SD30-1550
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) field service technician submitted complaint alleging that the cotter pins that holds the wheel assembly together on the integrity 270 sterilizer carriage rack were coming loose.If a wheel comes off the rack there is a risk of the rack tipping and contents falling.
Additional Manufacturer Narrative
There is no new action implemented for this event.Evaluation concluded: 1) the instrument loading rack in/out test (repeated test), equivalent to seven (7) years of sterlizer operation was conducted and it was concluded that the wheels do not fall off under normal operation.As the facility reported the event, the customer uses multiple transfer carts and loading racks and it is likely the transfer cart/loading rack came into contact with one anotehr while moving where external force may have contributed to snap the pin, where the wheel came off.2) there is no risk per the risk assessment/evaluation.3) there were no other complaints/reports relating to this event.
Event or Problem Description
Skytron field service technician submitted complaint alleging that the cotter pins that holds the wheel assembly together on the integrity 270 sterilizer carriage rack were coming loose.If a wheel comes off the rack there is a risk of the rack tipping and contents falling.

• Brand Name: SKYTRON
• Common Device Name: INTEGRITY 270DD-RRSR
• Manufacturer (Section D): SAKURA SEIKI, CO., LTD.; 46-1; shinden; chukima city, nagano, jpn 387-0 018; JA 387-0018
• Manufacturer Contact: david rothkopf ; 46-1; shinden; chijuma city, nagano, jpn 387-0-018 ; JA 387-0018
• MDR Report Key: 12571611
• Report Number: 3009685834-2020-00001
• Device Sequence Number: 1295954
• Product Code: FLE
• UDI-Device Identifier: 10841736100117
• UDI-Public: 10841736100117
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: G-SD30-1550
• Device Catalogue Number: INTEGRITY 270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown