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

Model Number FI-16RBS

Device Problem Material Fragmentation (1261)

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

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

This product is exempt, its only import for export.International medical device regulators forum (imdrf) adverse event reporting: (b)(4).

Event Description

Pentax medical was made aware of a complaint on 25th aug 2020 that occurred in the operating room during use outside of the united states in (b)(6).The reported incident is as follow "i noticed a break in the hi-16 rubber of fi-16rbs ((b)(4)) at the medical (b)(6) hospital.Regarding bending rubber tear, it is unknown whether it is before the inspection or during the inspection and it is currently being confirmed." on 27th aug 2020 additional information was received which stated the following "while the sputum of the bronchus was being aspirated, i noticed a rupture of the rubber covering the insertion part and stopped the inspection, restarted the aspiration with another endoscope, and said the procedure was completed safely.There is no reprimand from the doctor in charge, and another fiber is used to drop the coated rubber fragments into the body.I did not find out even during continuous suction, and it seems that the current condition of the patient is not bad.Regarding the accident report to the hospital, i instructed the nurse to report the delayed procedure, but i heard that i think it will not be important." based on gfe information collected from the end user, it was stated that the endoscope was used during the procedure.There was no medical intervention such as additional anesthesia/or extended hospitalization.However, there was a delay in procedure and there was no possibility of the patient being infected.(b)(6) complaint investigation is as follows "according to an interview with the facility, it is unknown whether the final use was the same several years ago and at that time.The cause is presumed to be damage to the insertion part due to aging deterioration because it has not been used for many years and has not been inspected." (b)(6) investigation conclusion is as follows "hearings were conducted with the doctors and nurses in charge of use when this event occurred.All removed with another scope, no health hazard.Due to this event, there are no problems with safety and effectiveness in the hospital and there is no health hazard, so the repair of the actual product has been completed.It was suggested that thorough inspections before and after use should be carried out." on 25-nov-2020, a device history record(dhr) review for model fi-16rbs, serial number (b)(4) was performed under (b)(4), the dhr review confirmed the endoscope was manufactured on 15th mar 2010 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 196-0 012; 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: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 11407126
• MDR Text Key: 234558154
• Report Number: 9610877-2021-00004
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FI-16RBS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR