MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP

Model Number FI-16RBS

Device Problem Optical Problem (3001)

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

Event Date 09/21/2021

Event Type  malfunction  

Event Description

Due to increased airway secretions, the patient needed fiberoptic bronchoscopy for treatment.All materials were prepared and sterile sheets were laid.At the beginning of the treatment, it was found that the light source was not bright enough to observe the patient's airway normally, so the treatment was ended.Replaced the spare scope and restarted the treatment.No harm was caused to the patient.This event occurred at the time of during use.

Manufacturer Narrative

This device is not distributed in us so that unique identifier is blank.This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information: h4:device manufacture date.Evaluation summary: after long-term use, the lamp closed to service life , the light was weak which caused dark image.The distributor reminded hospitals to be aware of the lifespan of their accessories.

• Brand Name: PENTAX
• Type of Device: FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP
• 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: 12580579
• MDR Text Key: 282287306
• Report Number: 9610877-2021-01096
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/24/2022

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
• Device Operator: Health Professional
• Device Model Number: FI-16RBS
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1