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

Model Number FNL-7RP3

Device Problem Excessive Heating (4030)

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

Event Type  malfunction  

Manufacturer Narrative

Adverse event: international medical device regulators forum (imdrf) adverse event reporting.Health effect clinical code: no clinical signs, symptoms or conditions.Health effect impact code: no health consequences or impact.Medical device problem code: excessive heating.Component code: light source.Type of investigation: type of investigation not yet determined.Investigation findings: results pending completion of investigation.Investigation conclusions: conclusion not yet available.

Event Description

Pentax medical was made aware of a complaint that was noted in the operating room after the procedure in the (b)(6) region.The reported complaint "after using the scope, the surface of the lg prong produces high temperature.The lg prong wasn't isolated which caused the surgery placemat to be burnt and it could be the risk of fire." involving the pentax product, model fnl-7rp3.No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported.However, the information reasonably suggests that if the malfunction recurs while in use with pentax product is likely to cause or contribute to a death, serious injury, or other significant/important medical event as defined in 21 cfr 803, therefore this event is reportable.A dhr cannot be performed for this device since the serial number cannot be confirmed.

• Brand Name: PENTAX
• Type of Device: FIBER NASO PHARYNGO LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 11495033
• MDR Text Key: 248483456
• Report Number: 9610877-2021-00033
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333070909
• UDI-Public: 04961333070909
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K951196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FNL-7RP3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2020
• 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: Reuse
• Patient Sequence Number: 1