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

Model Number ED-3490TK

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The long term loaner device was previously returned to pentax medical from a customer on 19-nov-2020 and inspection of the unit was performed under service order (b)(4) where the quality control inspector documented the following codes on 20-nov-2020: distal cap - fixed type failed epoxy seal integrity inspection, air/ water nozzle clogged with inorganic debris, up/ down control knob/ lever markings faded, istal tip annual maintenance, passed dry leak test, passed wet leak test, elevator body sticking, air/ water socket cylinder o-ring chipped, prism scratched, right/ left control knob markings faded, fluid invasion not observed in pve connector, bending rubber mild discoloration, light carrying bundle distal cover glass single chipped, sluggish air delivery function, sluggish water delivery function, fluid invasion not observed in control body, image mild spot.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, deflector operating wire, lcb distal cover, objective prism assy, distal case/cap, o-ring(0.5x1.3) imp-1, segment staycoil assy imp-c/pb-free, bending rubber.The endoscope is awaiting repair or approval by final qc as of 14-dec-2020.

• Brand Name: PENTAX
• Type of Device: 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: 11008613
• MDR Text Key: 255316391
• Report Number: 9610877-2020-00250
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333229611
• UDI-Public: 04961333229611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/20/2020

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
• Device Operator: No Information
• Device Model Number: ED-3490TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NOT ISSUED YET
• Patient Sequence Number: 1