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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJIFILM CORPORATION PB2020-M; MINI PROBE PB2020-M
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FUJIFILM CORPORATION PB2020-M; MINI PROBE PB2020-M Back to Search Results
Model Number PB2020-M
Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2018
Event Type  malfunction  
Event Description
A bronchoscopy was performed at a facility outside the us, with the subject fujifilm mini probe pb2020-m, fujifilm bronchoscope eb-530s and the olympus guide-sheath sg-200c, which is a component of the disposable olympus guide-sheath kit.The mini probe got stuck when it was being removed from the guide-sheath; the doctor removed it with force.When the mini probe came out, an exterior piece (diameter 1.4 mm, length 50 mm) at the distal end was gone.Attempts were made to retrieve the piece of the mini probe that came off; however, they were unsuccessful, as it became caught in the deep part of the patient's anatomy.The patient was discharged the following day.The fujifilm mini probe pb2020-m was inspected upon return.The cross section of the breakage is being analyzed in order to determine the cause of the breakage.The investigation is ongoing and a follow-up report will be submitted upon completion of the assessment.
 
Event Description
A bronchoscopy was performed at a facility outside the us, with the subject fujifilm mini probe pb2020-m, fujifilm bronchoscope eb-530s and the olympus guide-sheath sg-200c, which is a component of the disposable olympus guide-sheath kit.The mini probe got stuck when it was being removed from the guide-sheath; the doctor removed it with force.When the mini probe came out, an exterior piece (diameter 1.4 mm, length 50 mm) at the distal end was gone.Attempts were made to retrieve the piece of the mini probe that came off; however, they were unsuccessful, as it became caught in the deep part of the patient's anatomy.The patient was discharged the following day.
 
Manufacturer Narrative
The fujifilm mini probe pb2020-m was inspected upon return.The cross section of the breakage is being analyzed in order to determine the cause of the breakage.The exterior of the fujifilm mini probe pb2020-m is tubular resin materials measuring 1.4mm in outside diameter and 2150mm in length.Different resin parts are bonded at 50 mm from the tip.The mini probe was inspected after the event at a fujifilm authorized service center.The bonding was found to have come off and the resin part (diameter 1.4 mm, length 50 mm) on the side of the tip was missing.Investigation of root cause: it was investigated whether or not usual condition exists at the hospital in terms of clinical procedural technique and the reprocessing procedures.Clinical procedural technique: no significant difference was found in the procedural technique.Reprocessing procedures: no significant handling or procedure problems were found in the reprocessing steps.What occurred in the subject procedure: an interview with the physician did not give any insight into the potential root cause.Actual device investigation: we have confirmed this failure, but we can not clearly determine the root cause.If any additional relevant information becomes available a supplemental report will be sent.
 
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Brand Name
PB2020-M
Type of Device
MINI PROBE PB2020-M
Manufacturer (Section D)
FUJIFILM CORPORATION
798 miyanodai kaisei-machi
ashigarakami-gun, kanagawa 258-8 538
JA  258-8538
MDR Report Key7553301
MDR Text Key109762423
Report Number3001722928-2018-00051
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K171207
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPB2020-M
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
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