MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO COLONOCOPE - I10 STANDARD

Model Number EC38-I10L

Device Problems Corroded (1131); No Display/Image (1183)

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

Event Type  malfunction  

Event Description

Pentax medical was made aware of a complaint that occurred in the united states.The information provided indicated that there was no video image involving pentax medical video colonoscope model ec38-i10l, serial number (b)(4).The event was observed in the operating room during use.There was no report of patient injury, delay in procedure or an event that required medical intervention.

Manufacturer Narrative

This model is classified as import for export and not distributed in the united states, therefore 510k is not applicable.We do have similar model ec38-i10l-us available in the united states with a 510k number k131855.(b)(4).Good faith effort requests were sent and no additional information has been received as of 01-dec-2021.The customer owned endoscope was received by pentax medical for evaluation on 09-nov-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint documenting the following inspection findings: ccd circuit board corrosion, passed dry leak test, bending rubber glue cracking at insertion tube side, bending rubber glue cracking at distal side, endoscope failed electrical safety test - plct, passed wet leak test, customer complaint confirmed, hole in # 1 remote control button cover, mild moisture on pve electrical connector frame, pve electrical connector frame mild corrosion.The device will undergo repairs including and be returned to the customer once completed.Model ec38-i10l, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 09-nov-2021, a device history record(dhr) review for model ec38-i10l, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 20-feb-2015 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 20-feb-2015.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: customer reported no video image.The customer stated no accessory was used during the procedure and there were no patient/user injuries, adverse events, delay or medical intervention reported.Therefore, we checked the returned unit and confirmed that the ccd driver pcb corroded.Based on the result, we concluded that it was caused due to the worn out on the ccd driver pcb.

• Brand Name: PENTAX
• Type of Device: VIDEO COLONOCOPE - I10 STANDARD
• 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: 12910794
• MDR Text Key: 284898181
• Report Number: 9610877-2021-01567
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04961333172085
• UDI-Public: 04961333172085
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I10L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1