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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on discussion with fda on (b)(6) 2017, all inspectional failures are being reported as mdrs notwithstanding the fact that the presence of discontinuities, gaps or bubbles does not necessarily have either technical or clinical significance.Event problem and evaluation codes: no known impact or consequence to patient.Loss of or failure to bond.Actual device evaluated.Wear problem.Device repaired and returned.

Event Description

A customer device was returned to pentax medical on (b)(6) 2018 for routine service due to 522 pms study.Inspection of the unit was performed on (b)(6) 2018 where the quality control inspector found the following: distal cap - fixed type failed epoxy seal integrity inspection.Air/ water socket cylinder o-ring chipped.Passed wet leak test.Umbilical cable dent.Passed dry leak test.Customer complaint confirmed.Operation channel- primary mild resistance.The scope's repairs included the distal case/cap, which was replaced and/or resealed pursuant to the field correction, and returned to the user on (b)(6) 2018.

• 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 "temporary" ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 7652970
• MDR Text Key: 113247237
• Report Number: 9610877-2018-00325
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092710
• 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: 06/29/2018,06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 06/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2018
• Distributor Facility Aware Date: 06/22/2018
• Device Age: 63 MO
• Event Location: Other
• Date Report to Manufacturer: 06/29/2018
• Date Manufacturer Received: 06/22/2018
• 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