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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided in this report does not constitute an admission that the device caused or contributed to the reportable event.(b)(4).Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
Event or Problem Description
Pentax medical was made aware of a complaint on 31-oct-2019 stating "operation channel blocked" involving the pentax medical video duodenoscope model ed34-i10t-us, serial number (b)(4).The user also reported "stent stuck in op channel - demo - during the procedure".Pentax medical has made three good faith effort(gfe) attempts to obtain additional information; however, no addition information has been provided.No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported.The loaner duodenoscope was returned for evaluation on 07-nov-2019.During evaluation of the endoscope under service order (b)(4), the pentax medical service repair technician found an "accessory stuck in primary operational channel" confirming the customer's complaint and documenting the following additional findings on 19-nov-2019: passed dry leak test, bending rubber glue pinhole, passed wet leak test, middle light carrying bundle distal cover glass cracked.The device underwent repairs including the following components: deflector operating wire, deflector staycoil, bending rubber, air/water tube, lcb distal cover, deflector lever, objective prism assy, o-ring(0.5x1.3) imp-1.On 09-nov-2020, a device history record(dhr) review for model ed34-i10t-us, serial number (b)(4) was performed under (b)(4), the dhr review confirmed the endoscope was manufactured on 04-jun-2018 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 04-jun-2018.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 03-jul-2018.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 duodenoscope was put back into loaner inventory after being approved by final qc on 26-may-2020.

• 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: 10840131
• Report Number: 9610877-2020-00220
• Device Sequence Number: 3525644
• Product Code: FDT
• UDI-Device Identifier: 04961333240142
• UDI-Public: 04961333240142
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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: 11/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1