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

Model Number	OE-A63
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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
• Common Device Name: 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
• MDR Report Key: 9788361
• Report Number: 9610877-2020-00048
• Device Sequence Number: 1099265
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: OE-A63
• Device Lot Number: 0011019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1