MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO NASO PHARYNGO LARYNGOSCOPE

Model Number	VNL8-J10
Medical Device Problem Codes	Break (1069); Scratched Material (3020); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary it was caused due to the bending rubber worn out.In addition, we confirmed that the u/d knob broken, the ccd module cloudy (not clear view),and the lcb distal cover glass scratched; however, these are not related to the alleged complaint.Details of repair: replaced the u/d knob, bending rubber, ccd module, insertion flexible tube (ift), segment steel braid, lcb distal cover glass.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
Elongation of scope tip hifuku rubber.There was no abnormality in the leak check.This event occurred at the time of before use.There was no report of patient harm.

• Brand Name: PENTAX
• Common Device Name: VIDEO NASO PHARYNGO LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12171244
• Report Number: 9610877-2021-10188
• Device Sequence Number: 11602198
• Product Code: EOB
• UDI-Device Identifier: 04961333225354
• UDI-Public: 04961333225354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172156
• 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): 07/15/2021

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: VNL8-J10
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1