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

Model Number EG29-I10C

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

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

Event Date 01/11/2022

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.The device was returned to pentax for further evaluation on service order 3137555 where the user narrative was confirmed.The device is in the process of being repair where all defects found will be remediated and returned to the user upon completion.On (b)(6) 2022, a device history record (dhr) review for model eg29-i10c, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 24dec2019 under normal conditions, pass all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

(b)(6) was made aware of an event which occurred in the (b)(6) involving pentax endoscope model eg29-i10c.In the event reported, the user stated that the device have no air flow.The event timing is unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.

Manufacturer Narrative

H6 continued: international medical device regulators forum (imdrf) adverse event reporting health effect clinical code: 4582 no clinical signs, symptoms or conditions, health effect clinical code: 2645 no patient involvement, medical device problem code: 2541 failure to disconnect, component code: 4761 access port, type of investigation: 10 testing of actual/suspected device, investigation findings: 180 mechanical problem identified, investigation conclusions: 61 unintended use error caused or contributed to event.The user facility responded to a good faith effort request via email on 25-jan-2022 and reported the failure occurred during reprocessing on (b)(6) 2022.The product was removed from circulation immediately after the failure/event occurred and subsequently called in for service/replacement.The user facility also confirmed that they perform pre-procedural checks and for the product involved as well as follow any instructions for use of accessories and reprocessing.The endoscope was received by pentax medical for evaluation on 13-jan-2022.The endoscope was inspected by pentax medical service under service order (b)(4) on 14-jan-2022, and the technician was unable to confirm the initial customer complaint of blocked air channel, but service repair did note an accessory stuck in the primary operation channel, as well as documenting the following inspection findings: scope leak test function: wet leak test pass, scope electrical test function: dst electrical safety test fail, operation channel (primary): cut, operation channel (primary): stuck accessory/object, lg connector assy: fluid damage, lg connector assy: corroded.The endoscope was repaired and returned to the user facility on 16-mar-2022.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.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• 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: 13506266
• MDR Text Key: 285503832
• Report Number: 9610877-2022-00235
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333237586
• UDI-Public: 04961333237586
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

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-I10C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/10/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1