MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SUCTION/ SUCTION CHANNEL/ CONTROL VALVE FOR EG34-J10U

Model Number OF-B206

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model of-b171 is available in the usa with a 510k number k130206.Evaluation summary: it was caused due to the rubber seal and the o-ring on the suction valve worn out.This report is being filed as part of the pentax backlog management plan.

Event Description

This event occurred at the time of before use.There was no report of patient harm.The valve often stays fixed in the suction position.Despite the use of silicon oil.

• Brand Name: PENTAX
• Type of Device: SUCTION/ SUCTION CHANNEL/ CONTROL VALVE FOR EG34-J10U
• 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 07645 ; 8004315889
• MDR Report Key: 12200833
• MDR Text Key: 262640549
• Report Number: 9610877-2021-10197
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OF-B206
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2021
• 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: N
• Patient Sequence Number: 1