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); Corroded (1131); Fluid/Blood Leak (1250); Failure to Disconnect (2541)

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

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the united states within (b)(6).The customer reported that a cleaning brush was stuck in the channel involving pentax medical video gastroscope model eg-2790i, serial number (b)(4).The issue occurred during reprocessing, as such there was no patient involvement and no adverse event reported.This event is fda reportable for the potential of cross contamination.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

(b)(4)._ the customer responded to a good faith effort by pentax customer service on (b)(6) 2021, and the failure occuured during reprocessing with no patient involvement.The customer owned endoscope was received by pentax medical for evaluation on (b)(6)2021.The endoscope was inspected by pentax medical service under service order 3137334 and the service technician confirmed the customer complaint and documented the following: accessory stuck in suction tube, passed dry leak test, suction function low flow, passed wet leak test, pve electrical connector frame mild corrosion, fluid invasion not observed in control body, insertion tube markings mild discoloration at stage 1, customer complaint confirmed.The device will undergo repairs including the following components and be returned to the customer once completed: o-rings and seals, suction channel lg.Model eg-2790i, serial number a110552 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 eg-2790i, serial number a110552 was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the miyagi facility on (b)(6) 2013 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 (b)(6) 2013.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 (b)(6) 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 investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: no known adverse events.Refer to expiration date as complaint notification date.Customer reported brush stuck/broken in channel.Tier 2 therefore, we checked the returned unit and confirmed that the suction channel accessory.Based on the result, we concluded that it was caused due to the excessive force applied on the suction channel.In addition, we confirmed that the insertion flexible tube (ift) discolored, the control body fluid damage, and the lg cable connector corroded; however, they are not the main cause, and/or irrelevant to the alleged complaint.

• 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: 13296039
• MDR Text Key: 294025157
• Report Number: 9610877-2022-00050
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333150533
• UDI-Public: 04961333150533
• 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: Health Professional,User Facility
• 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: EG-2790I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1