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

Model Number EC34-I10L

Device Problems Break (1069); Corroded (1131); Fluid/Blood Leak (1250); Obstruction of Flow (2423)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.Pentax model ec34-i10l is classified as ife (import for export), therefore 510k is not applicable.A same model (ec34-i10l-us) is distributed in the usa only with 510k number k131855.

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, "rubber came out of the scope and hard to clean the channels" involving pentax model ec34-i10l/serial (b)(4).Additional information received from the facility contact confirmed the event occurred during the diagnostic procedure and no adverse events occurred.A boston scientific cold biopsy forceps 2.8mm lot # 26982769 ref # m00513410 was used during the procedure.The facility contact also confirmed the rubber material did not fall into the patient.In addition, the patient would not be recalled for further screening.The procedure was able to be completed with the device.The rubber material was not available as the facility discarded it.The device was returned to pentax on 07/01/2021.Pentax service inspectional findings included: bending rubber glue cracking at insertion tube side, pve electrical connector frame has severe corrosion, air/ water nozzle glue missing, bending rubber glue cracking at distal side, up angulation decreased, down angulation decreased, right /left angulation knob play, left angulation decreased, right angulation decreased, up/ down angulation knob play.Repairs were performed on the device which included replacement of the following components: o-rings and seals the device was shipped back to the facility on 07/14/2021.The device has been routinely serviced by pentax since install.

Manufacturer Narrative

Correction information: g6: follow up #1.H2:if follow-up, what type? h3:device evaluated by manufacture.H6: coding changed based on the investigation result.Additional information: h4:device manufacture date.Evaluation summary: result of investigation, we concluded that it was caused due to the physical damage applied on the operation channel.

• Brand Name: PENTAX
• Type of Device: VIDEO COLONOSCOPE
• 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: 12221107
• MDR Text Key: 282279587
• Report Number: 9610877-2021-00258
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04961333186822
• UDI-Public: 04961333186822
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC34-I10L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 76 KG