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

Model Number	ED34-I10T-US
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting.(b)(4).Type of investigation: testing of actual/suspected device.
Event or Problem Description
Pentax medical was made aware of an event on (b)(6) 2020 that occurred after reprocessing in the united states.The reported complaint that there is potential endoscope contamination as the endoscope failed channel check testing 3 times after reprocessing, involving the pentax medical video duodenoscope, model ed34-i10t-us, serial number: (b)(4).No patient involvement was reported.The customer owned duodenoscope was received by pentax medical for evaluation on 23-oct-2020.The duodenoscope was inspected by pentax medical a service repair technician under service order#: (b)(4), and documented the following inspection findings on 26-oct-2020: primary operation channel resistance, leak at # 1 remote control button cover, lcb distal cover glass modified cover glass chipped/cracked, air/ water socket cylinder o-ring chipped, right/ left brake knob markings faded, failed wet leak test, failed dry leak test, hole in # 1 remote control button cover, sluggish water delivery function, sluggish air delivery function, insertion tube mild discoloration at stage 1, insertion tube mild discoloration at stage 2, fluid invasion not observed in pve connector, fluid invasion not observed in control body.The duodenoscope underwent repairs including the following components: o-rings and seals, bending rubber, air/water tube, operation channel, angle wire, remote control button(1), o-ring(0.5x1.3) imp-1, o-ring (1.8x19.8), lcb distal cover glass.The video duodenoscope is currently awaiting organic resampling, and final qc approval as of 19-nov-2020.Pentax model ed34-i10t-us, serial number: (b)(4) has been routinely serviced at a pentax facility since the device was put into service on (b)(6) 2019.The investigation is currently in process as of 19-nov-2020.
Additional Manufacturer Narrative
Correction information g4:premarket identification pma/510(k).G6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information: h4:device manufacture date.Evaluation summary: three failed atp tests after endoscope reprocessing reported possible contamination.However, the atp test is a measure of cleanliness and could not confirm bacterial or viral contamination.The dhr stated that it passed all required inspections and was released.By november 2022, no additional information, including culture results, was available.No information affecting safety at this time.The cause of the atp failure could not be determined.

• 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
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 10874985
• Report Number: 9610877-2020-00196
• Device Sequence Number: 2863051
• Product Code: FDT
• UDI-Device Identifier: 04961333232956
• UDI-Public: 04961333232956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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: 10/23/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown