MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; C.A.P. HD DUODENOSCOPE

Model Number	ED34-I10T-US
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting: (b)(4).
Event or Problem Description
We received a notification on 28-dec-2020 regarding a failed wet leak test involving pentax medical video duodenoscope, model ed34-i10t-us, serial number (b)(4) at (b)(6).Good faith efforts phone calls were placed on 01-feb-2021 and 04-feb-2021, as well as an email on 04-feb-2021 to gather additional event details and to identify the manufacturer, model and lot number of the broken accessory.No other information has been provided as of 04-feb-2021.The customer owned endoscope was returned for evaluation on 04-jan-2021.During evaluation of the endoscope under service order (b)(4) and the technician documented an accessory stuck in primary operation channel as well as the following inspection findings on 05-jan-2021: image shadows, failed wet leak test, suction tube resistance, failed dry leak test, bending rubber pinhole, umbilical cable bump under pve root brace, light carrying bundle distal cover glass single chipped, prism scratched.The device underwent repairs including the following components: o-rings and seals, bending rubber, operation channel, objective prism assy, lcb distal cover glass, angle wire, suction channel lg, o-ring (0.5x1.3) imp-1, o-ring (1.8x19.8), 2-4 repair in process.Pentax medical model ed34-i10t-us, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 29-dec-2017.Instructions for use (ifu), includes the following warning section "after using operational/cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.The endoscope is awaiting repair or approval by final qc as of 04-feb-2021.Investigation is in-process.

• Brand Name: PENTAX
• Common Device Name: C.A.P. HD 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: 11283283
• Report Number: 9610877-2021-00054
• Device Sequence Number: 14312962
• Product Code: FDT
• UDI-Device Identifier: 04961333240142
• UDI-Public: 04961333240142
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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-I10T-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1