MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FORCEPS WINDOW REUSABLE 1.8DIA 180L

Model Number	KW-1818CS
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: it was caused due to an excessive force applied on the part inside the handle.Related mdrs: 9610877-2021-10121, 9610877-2021-10724, 9610877-2021-10725, 9610877-2021-10726.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
The forceps may or may not open after the handle operation.(when confirming at the hospital, confirm that it will open in about 1 second).As a result of checking, there was a catch when operating on the opening side, and there was a time lag between when the handle was operated and when it was opened.In addition, since defects were confirmed in the pre-use inspection, no health damage has occurred to patients or medical staff.It is the same device involved in five different events.

• Brand Name: PENTAX
• Common Device Name: FORCEPS WINDOW REUSABLE 1.8DIA 180L
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12285957
• Report Number: 9610877-2021-10723
• Device Sequence Number: 19628388
• Product Code: ODG
• UDI-Device Identifier: 04961333224463
• UDI-Public: 04961333224463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010740
• 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): 08/06/2021

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: KW-1818CS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1