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

Model Number	OF-B113
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number is unknown.If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Per the initial report, another of-b113 detached this morning.In the endo room #2 with dre larouche, the tubing went out of the black connector.Product did detach during an emr procedure with bleeding.However, another of-b113 was used to complete the procedure.This event occurred at the time of during use.There was no report of patient harm.
Additional Manufacturer Narrative
Correction information: g6: follow up #1.Evaluation summary: according to the contents of the report, it was speculated that the fitting of the connection part of the product became loose due to unintended usage (used to connect an aer that delivers a high-temperature disinfectant solution and an endoscope), and that the tube came off when the product was subsequently removed.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• 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 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 16200167
• Report Number: 9610877-2023-00004
• Device Sequence Number: 5627411
• Product Code: FDF
• UDI-Device Identifier: 04961333084050
• UDI-Public: 04961333084050
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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
• Operator of Device: Health Professional
• Device Model Number: OF-B113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown