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

Model Number G-SD30-1550

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 281431159
• Report Number: 3009685834-2020-00001
• Device Sequence Number: 1
• Product Code: FLE
• UDI-Device Identifier: 10841736100117
• UDI-Public: 10841736100117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G-SD30-1550
• Device Catalogue Number: INTEGRITY 270
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1