MAUDE Adverse Event Report: HOYA CORPORATION PENTAX; VIDEO BRONCHOSCOPE

Model Number EB-1970K

Device Problems Device Reprocessing Problem (1091); Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)

Patient Problem Exposure to Body Fluids (1745)

Event Type  malfunction  

Event Description

(b)(6) hospital returned video bronchoscope eb-1970k (s/n: (b)(4)) to (b)(6) medical.During inspection of the scope, the pentax quality control inspector noticed a broken piece of accessory lodged inside the biopsy channel beginning from the inlet t-piece and most likely the entire channel assembly, but not showing at the distal tip.The staff at (b)(6) hospital were not aware an accessory was lodged in the scope until after the scope had been reprocessed and was being used in the next case; therefore, indicating possible potential exposure to one pt.

• Brand Name: PENTAX
• Type of Device: VIDEO BRONCHOSCOPE
• Manufacturer (Section D): HOYA CORPORATION; tokyo ; JA
• Manufacturer (Section G): HOYA CORPORATION PENTAX LIFE CARE TOKYO OFFICE; 2-7-5 naka-psjao, shinjuku-ku; tokyo 161- 8525; JA 161-8525
• Manufacturer Contact: anastasia vlamis ; 3 paragon drive; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 3834796
• MDR Text Key: 4408284
• Report Number: 2518897-2014-00004
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/02/2014

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: EB-1970K
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2014
• Distributor Facility Aware Date: 02/19/2014
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: COOK DILATION BALLOON (NON-PENTAX ACCESSORY)