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Model Number EG29-I10
Device Problem Failure to Clean Adequately (4048)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2019
Event Type  malfunction  
Event Description
Pentax medical became aware of a report on 26-jun-2019 stating that the forward water jet channel on three customer-owned pentax medical gastroscopes model eg29-i10 (serial (b)(4)) were not cleaned or reprocessed in accordance with the pentax reprocessing instructions for use (rifu). According to the facility, it learned of the issue on 26-june-2019, and communicated to pentax that the issue potentially dates back to when the devices were first placed in service in (b)(6) 2018. The pentax global chief clinical officer held a conference call with the facility senior executive team on 27-jun-2019 to gather additional details and determine next steps. The facility communicated that the three customer-owned eg29-i10 gastroscopes were removed from service and quarantined at the facility since (b)(6) 2019 and that the devices were not used on additional patients after that date. The facility also communicated that foreign liquid was evacuated from at least one of the devices upon flushing the forward water jet channel. The three customer-owned eg29-i10 gastroscopes were shipped to the account in january 2018, but, according to the facility, were not used or placed into clinical service until (b)(6) 2018. On 12-july-2019, pentax learned that one pentax-owned loaner scope (serial (b)(4)) was placed into service at the facility during normal repair of one of the facility-owned devices and then removed from the account, reprocessed and inspected by pentax personnel, before being placed back into the pentax loaner pool. Based on the facility electronic health records, pentax was informed that the 3 facility-owned devices and 1 pentax-owned loaner device were used in a total of 998 procedures. A mdr is being filed for each of these procedures. A review of the service history for pentax model eg29-i10/serial (b)(4) shows the device involved in this mdr has not been returned to a pentax facility for repair/service since the device was put into service at the facility in (b)(6) 2018. At the time of sale, pentax model eg29-i10 gastroscopes were packaged with rifu s019-r05 and product bulletin mk-625 rev d. On 28-jun-2019, pentax issued return material authorizations for the 3 facility-owned devices to be returned to pentax for inspection and microbiological culturing. Pentax also shipped three loaner devices the same day (model eg29-i10) to provide on-site training so the facility could continue to provide clinical care for their patients. Pentax service completed an in-service with the facility on 28-jun-2019 for gastroscope model eg29-i10. During the in-service, the pentax service trainer documented the facility's use of a boston scientific enzymatic detergent that was not evaluated for compatibility with pentax endoscopes and endochoice cleaning brushes that were not validated for use with pentax endoscopes. The pentax service trainer also recommended in-service training on proper use of the medivators aer being used and its associated products. Pentax model eg29-i10/serial (b)(4) was received by pentax on 01-july-2019 and inspected by pentax service the same day. Inspection findings included the following: operation channel - primary slice by accessory; air/water socket cylinder o-ring chipped; air nozzle clogged with inorganic debris; passed wet leak test; passed dry leak test; hole in #1 remote control button cover; insertion tube mild scratches at stage 1; fluid invasion not observed in control body or in pve connector; sluggish air delivery function. The operation channel and forward water jet channel were sampled on (b)(6) 2019, prior to repairs. A device history review was performed on 02-jul-2019 which confirmed the gastroscope (pentax model eg29-i10/serial (b)(4)) was manufactured under normal conditions, passed all required inspections, and was released accordingly. In addition, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed. The pentax global chief clinical officer visited the facility on 02-jul-2019 and met with the facility leadership team. Documentation from the on-site in-service was provided to the facility and the facility communicated plans to notify patients and initiate changes to its reprocessing procedures. Pentax notified fda about the incident on (b)(6) 2019. The sampling performed on (b)(6) 2019 yielded the following results: operation channel - no growth; study number (b)(6); forward water jet channel - (1) negative rods - cupriavidus species, (2) negative rods - stenotrophomonas pavanii/ pseudomonas geniculate; study number (b)(6). Because of delayed delivery and testing of the (b)(6) sample, the operation channel and forward water jet channel were resampled on (b)(6) 2019, prior to repairs. Results from the microbiological re-culturing are pending. There have been no reports of patient infection or death from this event. This mdr is one of 998 that are being filed in relation to an incident reported at a single hospital.
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Brand NamePENTAX
Manufacturer (Section D)
tsutsujigaoka 1-1-110
akishima-shi, 196-0 012
JA 196-0012
MDR Report Key8811666
MDR Text Key151732670
Report Number2518897-2019-00048
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/22/2019,06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEG29-I10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/26/2019
Device Age2 YR
Event Location Hospital
Date Report to Manufacturer07/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/22/2019 Patient Sequence Number: 1