MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; TUBE,IRRIGATION FOR 30/40 SERIES

Model Number	OF-B113
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned from customer to manufacturer.Lot# was unavailable.According to customer's allegation, "3rd party irrigation tubing has an over plastic" and there was no other allegation to our product.As the customer connected the connection port (made of plastic) of 3rd party irrigation tube (manufactured by medivator) to the ruler port (metal)of water jet irrigation tube (of-b113) , the plastic connection port bit on the metal ruler port.We checked our complaint record and there was no same allegation.We concluded this is isolated issue and no further action is required.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
The screw pitch of 3rd party irrigation tubing has an over plastic that makes it difficult to unscrewing the tubing of-b113.It is necessary to replace the three boxes purchased by our customer by another batch.This event occurred at the time of after use.There was no report of patient harm.

• Brand Name: PENTAX
• Common Device Name: TUBE,IRRIGATION FOR 30/40 SERIES
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12140742
• Report Number: 9610877-2021-10006
• Device Sequence Number: 4259979
• Product Code: FDF
• UDI-Device Identifier: 04961333084050
• UDI-Public: 04961333084050
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131855
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: OF-B113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1