MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO DUODENOSCOPE

Model Number	ED34-I10T2-US
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Pentax medical was made aware of a complaint that occurred in the united states.It was reported to pentax medical from the facility that there was decreased elevator angulation with pentax medical video duodenoscope model ed34-i10t2-us, serial number (b)(4).A narrated video of the issue was provided by the customer and indicated that the elevator was slow to retract at all when the endoscope was at a 90 degree angle.Distal end cap 0011120 was being used with the duodenoscope.The customer owned endoscope was received by pentax medical for evaluation on 29-jul-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint as "elevator deflection movement is sluggish" and documented the following inspection findings: lcb distal cover glass modified cover glass chipped/cracked, passed wet leak test, passed dry leak test.The device underwent repairs including the following components: o-rings and seals, o-ring(0.5x1.3) imp-1, deflector operating wire, lcb distal cover glass.The endoscope is awaiting repair and approved by final qc as 16-aug-2021.This is the first time pentax model ed34-i10t2-us, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service.

• Brand Name: PENTAX
• Common Device Name: VIDEO DUODENOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12331957
• Report Number: 9610877-2021-00546
• Device Sequence Number: 11436937
• Product Code: FDT
• UDI-Device Identifier: 04961333240135
• UDI-Public: 04961333240135
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K192245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

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: ED34-I10T2-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1