MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; CO2 FEEDING ADP

Model Number OF-G11

Device Problems Corroded (1131); Unintended Movement (3026)

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

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.This device is not distributed in us so that unique identifier is blank.

Event Description

Of-g11 after washing, fixing becomes corroded and no longer works.This event occurred at the time to before use.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: the event was presumed to be due to corrosion of the mounting screws or mounting with excessive force.Non-compatible peracetic acid-based disinfectants are sometimes used in facilities within the emia zone, and corrosion (pitting) progresses in the mounting screws of brass products due to long-term use.It is believed that this corrosion caused the thin-walled portion to become deformed, making it difficult to attach and detach the product.Alternatively, simply tightening with excessive force may cause galling, making it difficult to remove.

• Brand Name: PENTAX
• Type of Device: CO2 FEEDING ADP
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• 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: 15585300
• MDR Text Key: 303729418
• Report Number: 9610877-2022-00571
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K951579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OF-G11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1