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

Model Number FI-10RBS

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.International medical device regulators forum (imdrf) adverse event reporting (b)(4).

Event Description

Pentax medical was made aware of an event that occurred at a facility outside the united states.The reported complaint is as follows "when the scope was pulled out from the patient, it seemed that the bending rubber dropped out.Thursday, (b)(6) : when i used fi-10rbs serial (b)(4) from the patient, one part of the insertion part was missing.The patient's condition seems to be okay for now." involving the pentax medical fiberscope.The endoscope was received at the manufacture for further evaluation and investigation.The investigation is as follows: when i checked the actual product, the eyepieces and other parts were deteriorated in addition to the cfb flexible tube.According to the interview survey, the number of cases until the event occurred is "it is said that it is used only once or twice a year, and that it has been used for the first time in a while".Since it has never been repaired since it was delivered in (b)(6), it is presumed that it is due to aged deterioration (hydrolysis) of the cfb flexible tube.Precautions before use in the package insert (h031) states [before use, check that there are no abnormalities on the surface of the insertion part (surface scratches, surface cloudiness, catching, peeling, dropping, etc.)] is there.The manufacture conclusion is as follows: it was proved that the patient was also radiographed and confirmed to be safe, and this case was judged to have no problem.On 25-nov-2020, a device history record(dhr) review for model fi-10rbs, serial number (b)(4) was performed under (b)(4), the dhr review confirmed the endoscope was manufactured on 19-sep-2019 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.

• Brand Name: PENTAX
• Type of Device: FIBER INTUBATION SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 11407167
• MDR Text Key: 273143306
• Report Number: 9610877-2021-00001
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2020

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: FI-10RBS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2006
• 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
• Patient Age: 49 YR
• Patient Weight: 73