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

Model Number EPK-I5010

Device Problems Device Emits Odor (1425); Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint that occurred in the united states.The customer heard a rattling noise and smelled burnt plastic involving a pentax medical video processor, model epk-i5010, serial number (b)(4).The sales representative responded to a good faith effort attempt via email on 16-jul-2021 and stated that he helped pack up the processor and heard something like a loose screw bouncing around inside the processor.The timing and location of the initial event reported by the customer is unknown.The customer owned processor was received by pentax medical for evaluation on 20-jul-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint and documented the following inspection findings: front cover cracked, limit switch actuator plate(2) bent, ball plunger damaged, lamp low output, scope connector handle loose, air socket tube leaking.The technician also noted the control panel was cracked on the lower left bottom corner underneath of the power switch.Lamp is loose from the cartridge and from the mounting frame intermittent not igniting then goes to auxiliary light.Has low light output at 560 hrs of used need to be replace.Locking shoulder screws are loose and rattling inside of the unit.Scope limiter switch is worn out and so is the ball plunger.Air outlet receptacle is loose, can't hold firmly.The device underwent repairs including the following components: ball plunger, control panel unit, cable to limit sw, air outlet assy, lamp for epk-i5010 w/o housing.This is the first time pentax model epk-i5010, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service.The endoscope is pending repair and approval by final qc as of 07-jul-20201.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

Manufacturer Narrative

Evaluation summary: the device was returned, but the cause could not be determined because based on the information obtained at this time, it is difficult to identify the failure phenomenon.Correction information g6: follow up #1.H2: if follow-up, what type? h3: device evaluated by manufacturer? h6: coding changed based on the investigation.Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Type of Device: VIDEO PROCESSOR
• 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: 12293410
• MDR Text Key: 265582219
• Report Number: 9610877-2021-00424
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

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
• Device Operator: Health Professional
• Device Model Number: EPK-I5010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1