MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTIC BRONCHOSCOPE 2.2C 4.9TP 600L

Model Number	FB-15V
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We checked the returned unit and confirmed that the objective lens unit was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the objective lens unit.In addition, we confirmed that the u/d pulley wire fluid damage, the insertion flexible tube (ift) buckled, the operation channel leak, the bending rubber leak, the ocular dirty, the image guide fiber bundle (cfb) dirty, the lg prong top dirty, the lg prong top loosened, the objective lens unit disinfections damage, the lcb distal cover glass disinfections damage, the insertion flexible tube (ift) worn out, the light guide cable worn out, the angle wire hard to move, and the ocular discolored; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Video image failure(objective lens broken).

• Brand Name: PENTAX
• Common Device Name: FIBEROPTIC BRONCHOSCOPE 2.2C 4.9TP 600L
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 16100348
• Report Number: 9610877-2023-50023
• Device Sequence Number: 20401946
• Product Code: EOQ
• UDI-Device Identifier: 04961333072798
• UDI-Public: 04961333072798
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K951199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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: FB-15V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown