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 customer owned device was previously returned to pentax medical from a customer on 20-nov-2020 and inspection of the unit was performed under service order (b)(4) where the quality control inspector documented the following codes on 30-nov-2020: distal cap - fixed type failed epoxy seal integrity inspection, primary operation channel resistance, prism scratched, bending rubbersevere discoloration, distal cap/ case cracked, biopsy insulation ring deformed, image blackout, middle lcb distal cover glass glue is missing, passed wet leak test, passed dry leak test.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, distal end w/ccd-m imp-t pb-free/nt, adjusting collar, angle wire, bending rubber, distal case/cap, distal case attaching screw, rl pulley assy, ud pulley assy, electrical connector assy, o-ring(0.5x1.3) imp-1, deflector operating wire, deflector staycoil.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: 11008845
• MDR Text Key: 255318589
• Report Number: 9610877-2020-00253
• 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,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/30/2020

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: 11/20/2020
• Initial Date Manufacturer Received: 11/30/2020
• 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