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

Model Number FI-16RBS

Device Problem Flaked (1246)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product code is class 1, exempt from fda 510k.(b)(4).

Event Description

Pentax medical became aware of a report on (b)(6) 2019 for an event which occurred in the operating room during use in (b)(6) stating the an unrepaired pentax medical portable intubation fiberscope, model fi-16rbs, serial number (b)(4) had fragments of the coated rubber dropped into the patient 's body.The fragments of the rubber covering that fell into the body were removed by doctors and others.Additional information was noted the user first used a pentax medical model fi-9rbs (brand-new device) to conduct awake intubation during liver surgery.However, the insertion was not successful, therefore the fiberscope, model fi-16rbs was used instead.The device was damaged in the bronchus.The broken pieces were retrieved, but according to the chief nurse, there is a possibility of existing remaining pieces.The physician stated that there was no issue.As for the cfb (coherent fiber bundles) flexible tube material, relevant information was provided from the sales representative on (b)(6) 2019, from active medical and the chief nurse.Additional details of the product were provided from the manufacturer on 18jun2019.The staff at the anesthesiology division are handling the device control and reported the damaged area of the cfb flexible tube (approximately 28mm), there were no remaining broken pieces.There is no service contract with this hospital, so regular inspections have not been performed.Since its sale in 2004 it has never been repaired by pentax medical.Since the fiberscope was most recently returned to the user facility as an unrepaired return on 20nov2018, the customer had added a red sticker directly onto the fiberscope with the date 29nov2018 and (b)(6) writing on the sticker that states [ift peels off.Use until broken.].Although the fiberscope was not returned to the manufacturer, images were provided showing the condition of the fiberscope, including worn, damaged, cracked and split tubing, and missing coating.Pentax medical is filing this medwatch as a reportable malfunction because there was no patient injury reported due to the pieces of foreign material that fell into the patient and no medical intervention performed to prevent permanent impairment or damage to the patient.

• 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: 8712000
• MDR Text Key: 204700896
• Report Number: 9610877-2019-00224
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2019,02/01/2019

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-16RBS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2019
• Distributor Facility Aware Date: 02/01/2019
• Device Age: 15 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2004
• 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