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

Model Number FB-15BS

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of a report for an event which occurred in (b)(6) stating an incident occurred during a bronchoscopy, during the withdrawal of the endoscope in the left nostril of a patient.The customer stated "during the withdrawal of the endoscope from the left nostril of a female patient while the device has no angulation and it doesn't show leakage, we feel some difficulty to withdrawal it.By forcing we arrive to withdrawal it and we notice a cut of the membrane.The device in pre-disinfection doesn't present problems." additional information from the sales representative stated general anesthesia was administered to the patient and no injuries occurred to the patient.The patient will be recalled to determine if any post traumatic injury has occurred.No cannula (tube) or any other instrument was used during the procedure.In addition, no damages/failures were noted during device inspection prior to the procedure.The device involved in the event was sent to pentax for evaluation.The pentax inspectional findings confirmed several cuts in the length of the insertion flexible tube (ift), broken bending rubber glue, and several scratches on the surface of the ift and on the surface of the bending rubber.No issues were detected with the angulation during evaluation.The investigation performed by pentax europe concluded the damages are indicative of massive external force possibly due to mishandling of the product during reprocessing or transport.

• Brand Name: PENTAX
• Type of Device: FIBER 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: krishna govindarajan ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 6401159
• MDR Text Key: 69840724
• Report Number: 9610877-2017-00009
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K951199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2017,02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FB-15BS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2017
• Distributor Facility Aware Date: 02/13/2017
• Date Report to Manufacturer: 03/13/2017
• Date Manufacturer Received: 02/13/2017
• 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: N
• Patient Sequence Number: 1