MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CONNECTING TUBE; ENDOSCOPE REPROCESSOR ACCESSORIES

Model Number	MAJ-1500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- (b)(6) (user facility complete address captured here due to character limitation in section) the evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the connecting tube disassembled when sliding it to the scope.The issue occurred during preparation for reprocessing.The intended procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
Correction to d9: device will not be returned for evaluation.This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, it is likely the defect was due to the user¿s handling of the device that led to the reportable malfunction: the user may not have thoroughly read the instruction manual and not acknowledged that reprocessing should not be practiced with a modified connecting tube.However, based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.As described in instructions for maj-1500, chapter 5 ¿instrument compatibility¿, using incompatible equipment will compromise the effectiveness of cleaning and disinfection.¿ olympus will continue to monitor field performance for this device.

• Brand Name: CONNECTING TUBE
• Common Device Name: ENDOSCOPE REPROCESSOR ACCESSORIES
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19358749
• Report Number: 9610595-2024-10209
• Device Sequence Number: 3798354
• Product Code: FEB
• UDI-Device Identifier: 04953170233937
• UDI-Public: 04953170233937
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: MAJ-1500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/10/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown