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

Model Number EG29-I10

Device Problems Partial Blockage (1065); Break (1069); Failure to Disconnect (2541)

Patient Problem 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 with a description of an unspecified object stuck in the channel involving pentax medical video gastroscope, model eg29-i10, serial number (b)(4).The timing and location of the observation are unknown at this time.There was no report of injury or event necessitating medical intervention.

Manufacturer Narrative

Continued: (b)(4).Multiple good faith effort requests for additional information were made with no response as of (b)(6) 2022.The customer owned endoscope was received by pentax medical for evaluation on 17-dec-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and although the technician confirmed the customer complaint that there was resistance in the suction tube there were several areas of severe crushing noted.No foreign material was noted as being found within the channels or endoscope.The technician doscumented the following inspection findings: distal body abrasion, distal body chip at channel opening at thinnest part, right light carrying bundle distal cover glass cracked, failed wet leak test suction tube resistance, failed dry leak test, insertion tube severe crush at stage 3, customer complaint confirmed, # 1 remote control button cover cracked, bending rubber leak at middle section, leak at # 1 remote control button cover, bending rubber cut insertion tube severe crush at stage 1.The device will undergo repairs including the following components and be returned to the customer once completed: o-rings and seals, insertion flexible tube assy, distal end assy with tubes, segment assy attaching screw, segment attaching screw, rl pulley assy, ud pulley assy, bending rubber, adjusting collar, angle wire, suction channel lg, remote control button(1), x-ring(1.8x19.6) gray.The endoscope is pending repair and final qc approval as of 13-jan-2022.Model eg29-i10, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.On (b)(6) 2021, a device history record(dhr) review for model eg29-i10, serial number (b)(4) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the miyagi facility on 15-mar-2019 under normal conditions.The endoscope was reworked for a bubble and passed required inspections, and was released accordingly.Also, there were no concessions and the dates of approval for shipment and actual date shipped were confirmed for 15-mar-2019.Instructions for use(ifu), includes the following warning section "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.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: refer to expiration date as complaint notification date.Customer reported accessory stuck in scope.The customer stated the suction channel has something stuck in it.Tier 2.Therefore, we checked the returned unit and confirmed that the suction channel resistance.Based on the result, we concluded that it was caused due to the physical damage applied on the suction channel.In addition, we confirmed that the remote control buttons cracked, the bending rubber leaky, the remote control buttons leaky, the bending rubber cut, the insertion flexible tube (ift) crushed, the distal body chipped, the lcb distal cover glass cracked, and the distal body scratched; however, they are not the main cause, and/or irrelevant to the alleged complaint.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE - 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: 13252915
• MDR Text Key: 291394866
• Report Number: 9610877-2022-00032
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• 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
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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: EG29-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1