MAUDE Adverse Event Report: NOVA CORPORATION PENTAX; UPPER GI VIDEO BRONCHOSCOPE

Model Number EB-1570K

Device Problem Fire (1245)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 04/23/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a pentax flexible bronchoscope had been in use for a while when the end burst into flames.The valleylab force fx 8 diathermy (s/n (b)(4)) had been set to 10 watts, delivering the energy down a karl storz cable 11770t lot yz.It had been noted that occasionally, there was no evidence of rf power leaving the probe tip.The patient was under jet ventilation high concentration oxygen while attempts were made to use diathermy to cauterize a metal stent.Internal burn marks were noted to the patient's lungs.As a precautionary step, the patient was admitted to hdu for observation.The patient was electively anesthetized again the following day, but was discharged on (b)(6) 2014 in good condition.This has been reported by the user to (b)(6).Pentax medical usa was made aware of the event on (b)(6) 2014.

Manufacturer Narrative

The device has been sent to pentax (b)(4) for investigation.First results reveal this is a user error as the valleylab force fx is not approved for use in bronchoscopy.Further more, the ifu of karl storz claims hf power must not be used in vicinity of metal parts of inside of an endoscope.

• Brand Name: PENTAX
• Type of Device: UPPER GI VIDEO BRONCHOSCOPE
• Manufacturer (Section D): NOVA 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 dr.; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 3932521
• MDR Text Key: 4574292
• Report Number: 2518897-2014-00007
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K131028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EB-1570K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2014
• Distributor Facility Aware Date: 05/01/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: KARL STORZ CABLE: 11770T LOT YZ; VALLEYLAB FORCE FX 8 DIATHERMY: SN (B)(4)
• Patient Outcome(s): Hospitalization; Other