MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS

Model Number FB-15RBS

Device Problems Collapse (1099); Fracture (1260)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.Lt was sent to the third party repair company.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Fiberoptic bronchoscope was used to aspirate sputum for the patient through artificial airway, but it was found that the scope surface was damaged and the tube was deflated and collapsed.The sputum suction effect was not good.There is a possibility that the damaged scope surface might be dropped easily and left in the patient's airway, so it could not be used.This event occurred at the time of during use.There was no report of patient harm.

• Brand Name: PENTAX
• Type of Device: FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS
• 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: 12764327
• MDR Text Key: 284683267
• Report Number: 9610877-2021-01477
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04961333070497
• UDI-Public: 04961333070497
• 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
• Report Date: 11/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB-15RBS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1