MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.0T 1050L

Model Number EG-2790I

Device Problems Partial Blockage (1065); Failure to Disconnect (2541); Device Damaged by Another Device (2915)

Patient Problem 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 an event that occurred at a facility in the united states.The user facility reported an accessory stuck in scope."customer reported accessory stuck in scope and resistance primary biopsy channel.The customer stated the dilator balloon is stuck in biopsy port/ channel.The customer also stated that a 20mm 3 stage dilator balloon, as an accessory, was used during the procedure and there were no patient/ user injuries, adverse events, delay or medical intervention reported." involving pentax medical video gastroscope model eg-2790i, serial number (b)(4).The customer owned endoscope was received by pentax medical for evaluation on 11-aug-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and during quality inspection the technician documented an accessory stuck in primary operation channel confirming the customers complaint and the technician also documented the following inspection findings: passed dry leak test, primary operation channel crimped at biopsy inlet t-piece, passed wet leak test, insertion tube mild discoloration at stage 1.The device underwent repairs including the following components: o-rings and seals, operation channel, adjusting collar, angle wire, angle wire with coat, bending rubber, rl pulley assy, ud pulley assy.Model eg-2790i, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service.On 17-aug-2021, a device history record (dhr) review for model eg-2790i, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the (b)(4) facility on 11-jun-2014 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 11-jun-2014.Instructions for use (ifu), includes the following warning section 2-1-3, 3) "after using operational/cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/ suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/ cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/ suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.The endoscope is awaiting repair and approved by final qc as of 30-aug-2021.This event meets the requirements for fda reportability.

Manufacturer Narrative

Evaluation summary: the cause is thought to be that the brush used by the user during cleaning was broken and remained in the pipe.Pentax has added a method for alerting and detecting in ifu in the event, and also implemented field action.The event was not a clogged foreign object that was unknowingly used on the next patient, but was successfully detected and a complaint was reported.Correction information g6: follow up #1 h2: type of follow up h6: coding changed based on the investigation result.Additional information d4: udi h7: remedial action.

• Brand Name: PENTAX
• Type of Device: HD VIDEO GASTROSCOPE 2.8C 9.0T 1050L
• 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: 12388060
• MDR Text Key: 280955393
• Report Number: 9610877-2021-00555
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-2790I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1