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

Model Number MAJ-2113

Device Problems Crack (1135); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Customer reported two events of failed connecting tube devices of different model numbers for the oer-elite automatic endoscopy reprocessor (aer).These events are captured with patient identifiers (b)(6) (for auxiliary water channel) and (b)(6) (for suction channel).This is for the patient identifier (b)(6).The device is returned, and an evaluation completed for it.The device was returned in its original packaging.A visual inspection on the device in as received condition was performed.The inspection of the connecting tube started from the endoscope side connector and scratches on stainless-steel of the outer ring were observed.It was verified that the connector and outer ring was able to twist in place on to the auxiliary water inlet as intended.Additionally, the reprocessor connector of the connecting tube was also inspected to verify its condition.Once inspected, it was noted that there were no cracks, break, rip, scratches, attached debris, or other irregularities.The user¿s complaint of not sealing onto the oer-elite could not be confirmed or replicated as no oer-elite test device was available for testing.The user¿s complaint of cracks was not confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Customer returned the device as the device cracked and would not seal onto the automatic endoscopy reprocessor.There is no patient involvement.

Event Description

Addendum dec 29, 2023: the malfunction occurred in the automatic endoscopy reprocessor (aer).The plastic seemed cracked and caused the aer to cancel loads.

Manufacturer Narrative

Additional information has been received for this event from the customer and for device evaluation.This supplemental report is being submitted to provide this information.Exact event date is not known.Event occurred in november 2022.The device was manufactured in august 2012.The device history record could not be reviewed since the supplemental lot number is not available.Since the breakage of the device nor loose connection could be confirmed, it is possible that something (such as foreign material, etc.) was caught between the connector of connecting tube and the connector in reprocessing basin during connection and therefore connecting tube could not be connected.User can detect the event by inspecting item in accordance with the following instructions for use.Preparation and inspection: move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.

• Brand Name: CONNECTING TUBE
• Type of Device: 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: 16067269
• MDR Text Key: 308243016
• Report Number: 9610595-2022-06253
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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
• Device Operator: Health Professional
• Device Model Number: MAJ-2113
• Device Lot Number: 28A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OER-ELITE