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

Model Number	ED-3490TK
Medical Device Problem Code	Loss of or Failure to Bond (1068)
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).
Event or Problem Description
The customer owned device was previously returned to pentax medical from a customer on 14-apr-2021 and inspection of the unit was performed under service order (b)(4) where the quality control inspector documented the following codes on 16-apr-2021: distal cap - fixed type failed epoxy seal integrity inspection, bending rubber pinhole, prism scratched, air/ water socket cylinder o-ring chipped, distal cap/ case cracked, failed wet leak test, failed dry leak test, light carrying bundle distal cover glass middle scratched, fluid invasion not observed in pve connector, fluid invasion not observed in control body, bending rubber leak at middle section.The duodenoscope's repairs will include the distal case/cap, which will be replaced and/or resealed pursuant to the field correction, along with the following parts , and returned to the user upon completion: o-rings and seals, lcb distal cover, objective prism assy, bending rubber, distal case/cap, o-ring(0.5x1.3) imp-1, o-ring (1.8x19.8).Model ed-3490tk, serial number (b)(4) , has been routinely serviced at a pentax facility since the device was put into service on (b)(6) 2016 the endoscope is awaiting repair or approval by final qc as of 06-may-2021.

• 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: 11783834
• Report Number: 9610877-2021-00098
• Device Sequence Number: 19703283
• Product Code: FDT
• UDI-Device Identifier: 04961333229611
• UDI-Public: 04961333229611
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K161222
• 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
• Remedial Action: Recall,Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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: No Information
• Device Model Number: ED-3490TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT ISSUED YET
• Patient Sequence Number: 1