MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE

Model Number EB15-J10

Device Problem Obstruction of Flow (2423)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

We checked the returned unit and confirmed that the aft suction tube clogged.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility.In addition, we confirmed that the insertion flexible tube (ift) coating damage, the light guide cable coating damage, the u/d knob broken, the remote control buttons perforated, the root brace rubber cracked, the insertion flexible tube (ift) crushed, the lg root brace rubber cut, the bending rubber dirty, the distal body dirty, the objective lens unit dirty, the lcb distal cover glass dirty, and the lg prong top loosened; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0630(air/water & jet water channels)"" and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is unknown.There was no report of patient harm.Air/water tube clogged.

• Brand Name: PENTAX
• Type of Device: VIDEO BRONCHOSCOPE
• 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
• MDR Report Key: 15376073
• MDR Text Key: 303083205
• Report Number: 9610877-2022-57610
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200678
• 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: 09/08/2022

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: EB15-J10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1