MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; SINGLE USE DISTAL END CAP WITH ELEVATOR

Model Number OE-A63

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2020

Event Type  malfunction  

Event Description

Pentax medical became aware of a report on 03mar2020 stating, "it's impossible to slide the guide wire.When the tip was removed, it was detached into two parts." involving pentax medical single use distal end cap with elevator, model oe-a63, lot number 0021108.Without considering accessories, pentax france mobile technician and physician performed several tests with a oe-a63: he wrote that there is not click felt during installation of the disposable end cap and following physician comments, the issue appears with a rate of 1 for 3 around.Depending the angulation applied on the bending section of the ed34-i10t2 #: (b)(4), the elevator doesn't return to the neutral position.When the insertion flexible tube is straight the elevator seems to work normally.The ed34-i10t2 #: (b)(4) will be sent to pentax (b)(4) for investigation on the elevator itself and on the connection of the oe-a63 with or without "click".Pentax (b)(4) mention that the complaint might be related to pe18-0090 / emea-19-100083 and pe20-0021 / emea-20-020019 and emea-20-030008.Poor attachment of oe-a63 distal end cap, but it is not confirmed.Retraining of the clinic personal recommended.

Manufacturer Narrative

The symptom "depending the angulation applied on the bending section of the ed34-i10t2 #a110240, the elevator doesn't return to the neutral position.When the insertion flexible tube is straight the elevator seems to work normally." is a normal behavior of the elevator due to becoming shorter of the length of elevator wire under the bending condition.Though the elevator is raised during the angulation applied on the bending section, it will be back to the normal position with passing the accessary.Event problem and evaluation codes: patient codes: (b)(4) no patient involvement, device codes: (b)(4) loose or intermittent connection,.

• Brand Name: PENTAX
• Type of Device: SINGLE USE DISTAL END CAP WITH ELEVATOR
• 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 (temporary) ; 3 paragon drive; montvale, nj ; 4315880231
• MDR Report Key: 9889212
• MDR Text Key: 228385241
• Report Number: 9610877-2020-00046
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K192245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2020

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: OE-A63
• Device Lot Number: 0021108
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1