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

Model Number OE-A63

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of a report on 04-feb-2020 stating, "pentax single-use elevator caps for duodenoscopes attach poorly and randomly with the risk of unhooking during the examination.Plus incomplete return to neutral position: damages the instruments and obliges to take out the endoscope and to restart the examination." involving single use distal end cap with elevator model oe-a63/lot 0011019.Based on communications between pentax and the user facility, no defects were identified with the disposable distal end cap, but rather the reported event appears to be a user facility handling usage problem.The resolution to the event will include retraining the clinical staff on how to connect the cap as per pentax medical operational instructions for use(ifu) for pentax medical video duodenoscope, model ed34-i10t2, including how to connect the cap with the endoscope and how to check the 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: 9788361
• MDR Text Key: 224677046
• Report Number: 9610877-2020-00048
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• 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: 0011019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: No
• 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