MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTIC GASTROSCOPE 2.8C 9.8T 1050L

Model Number	FG-29V
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is classified as import for export, therefore 510k is not applicable.Model fb-18v is available in the usa with a 510k number k951199.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the suction channel clogged.Based on the result, we concluded that it was caused due to the inadequate/insufficient reprocessing at the facility on the suction channel.In addition, our technician confirmed that the angle wire fluid damage, the segment fluid damage, the down pulley wire fluid damage, the left pulley wire fluid damage, the ocular fluid damage, the distal body broken, the cfb (coherent fiber bundle) broken, the lcb (light carrying bundle) broken, the lg prong top broken, the ethylene oxide gas valve (eog) broken, the control body corroded, the nozzle gluing missing, the segment steel braid deformed, the bending rubber leak, the u/d knob leak, the light guide cable for prong leak, the objective lens dirty, the lcb distal cover glass dirty, the u/d knob disinfections damage, the insertion flexible tube worn out, the air nozzle sharp, the water nozzle sharp, the bending rubber gluing discolored, the root brace rubber (lg control body) flared, and the ccd module with drive pcb distorted image; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0588(channel)"" and/or the risk analysis results, it was evaluated to submit mdr.
Event or Problem Description
The time of event is not during procedure.There was no report of patient harm.Operation/suction channel clogged.

• Brand Name: PENTAX
• Common Device Name: FIBEROPTIC GASTROSCOPE 2.8C 9.8T 1050L
• 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: gurvinder nanda ; 3 paragon drive; montvale, NJ 07645 ; 2015712318
• MDR Report Key: 18995792
• Report Number: 9610877-2024-52543
• Device Sequence Number: 7605326
• Product Code: FDS
• UDI-Device Identifier: 04961333166497
• UDI-Public: 04961333166497
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 03/28/2024

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: FG-29V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/28/2024
• 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