MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; NON-RIGID LARYNGOSCOPE

Model Number	FI-10RBS
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Codes	Bacterial Infection (1735); Death (1802)
Date of Event	06/07/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Three patients are mentioned in this mdr.The first patient indicated the presence of klebsiella pneumoniae at the time of the fibroscopy.The second patient underwent a fibroscopy with the same scope, after the first patient, and became infected with klebsiella pneumoniae.The third patient had a fibroscopy on (b)(6) 2017 with no reported adverse events.Mdr 9610877-2017-00406 is being submitted for the second patient involved in the cross contamination event.Mdr 9610877-2017-00407 is being submitted for the third patient who had a fibroscopy on (b)(6) 2017.(b)(4).Exempt = product code is class 1, exempt from fda 510(k).(exemption number e2015036).
Event or Problem Description
On 07/12/17, pentax medical was made aware of a report from the (b)(6) regarding an event in (b)(6) of cross contamination of klebsiella pneumoniae via a fiberscope (fi-10rbs serial no.(b)(4)) between 2 patients in cardiothoracic intensive care on (b)(6) 2017.(b)(6) reported that the first patient indicated the presence of the bacteria at the time of the procedure and the second patient tested positive following the procedure.(b)(6) reported that the 2 patients died from their underlying pathologies.(b)(6) reported that a third patient who had a fibroscopy on (b)(6) 2017 (before the endoscope was quarantined) was informed of the possible exposure and has no clinical signs of infection.(b)(6) further reported that the endoscope was still contaminated despite disinfection.The fiberscope was received by pentax (b)(4) from the facility on (b)(6) 2017 without any information about the contamination.The inspection found a perforated bending rubber.The fiberscope was repaired and reprocessed.Microbiological sampling was performed on the fiberscope on (b)(6) 2017.The sampling laboratory reported the following results: operating channel 1 cfu of bacillus sp., suction channel <1 cfu.A request for the device to be shipped from pentax (b)(4) to pentax europe (b)(4) was made on 07/13/2017.Pentax europe (b)(4) received the fiberscope ((b)(4)) on 07/17/2017.Inspection performed by pentax europe (b)(4) found the fiberscope to be leaky at the control body at the valve seat and appeared to have been previously repaired.In addition, the device looked worn, many scratches were noted and the insertion flexible tube was buckled and squeezed.Microbiological sampling was performed on the fiberscope on (b)(6) 2017.Results showed no critical pathogens, therefore the device met the hygienic microbiological requirements.A device history review was performed by the manufacturer which showed no discrepancies.The device is currently at pentax europe (b)(4).Pentax europe (b)(4) and pentax (b)(4) are currently investigating the event.

• Brand Name: PENTAX
• Common Device Name: NON-RIGID LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• MDR Report Key: 6789915
• Report Number: 9610877-2017-00406
• Device Sequence Number: 12969318
• Product Code: CAL
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: REFER TO H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2017
• Report Date (Section F): 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FI-10RBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Date Report Sent to FDA: 08/11/2017