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

Catalog Number EG29-I10

Device Problems Break (1069); Device Contamination with Body Fluid (2317)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of an event on 17-jan-2020 that occurred during reprocessing in the united states.The reported complaint was that the reprocessing technician at the user facility found possible blood in one of the endoscope channels after multiple manual cleanings in the reprocessing room involving a pentax medical video gastroscope, model eg29-i10, serial number (b)(4).No patient involvement was reported.The customer owned gastroscope was returned for evaluation on 28-jan-2020 and neither cleaning staff personnel noted seeing blood during processing.The duodenoscope was inspected by pentax medical service on 29-jan-2020 and the service repair inspector also did not identify blood.The following inspection findings were documented: air/ water socket cylinder o-ring chipped, passed dry leak test, passed wet leak test, right /left angulation knob play, insertion tube mild dent at stage 1.The gastroscope underwent repairs including the following components: o-rings and seals, distal end assy with tubes, bending rubber, adjusting collar, angle wire, suction channel lg, jet supply tube lg, air/water supply tube lg, biopsy inlet t-piece pb-free.The gastroscope was sampled in (b)(4) on 03-feb-2020 and test results received on 11-feb identifying passing results.The gastroscope was approved by final qc on 13-feb-2020 and returned to the customer on (b)(6) 2020 under the reference delivery number (b)(4).This is the first time pentax medical video gastroscope, model eg29-i10, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service on 07-aug-2019.The investigation is in-process.

Manufacturer Narrative

Correction information: g6: follow up #1 h2: if follow-up, what type? h3: device evaluated by manufacture h6: coding changed based on the investigation result.H4: device manufacture date.Evaluation summary: the duodenoscope was inspected by pentax medical service on 29-jan-2020 and the service repair inspector also did not identify blood.The device has been repaired.

• 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 ; 4315880231
• MDR Report Key: 9713489
• MDR Text Key: 221710065
• Report Number: 9610877-2020-00039
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EG29-I10
• Device Lot Number: K111519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• 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