MAUDE Adverse Event Report: HOYA CORPORATION PENTAX PENTAX; DIGITAL RADIAL ULTRASOUND SCOPE

Model Number EG36-J10UR

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

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 (b)(6).In the event reported by the pentax medical sales rep, the endoscope arrived with a broken connector and would not pass a leak test involving pentax medical video ultrasound gastroscope model eg36-j10ur, unknown serial number.The device was to be used in a demonstration.There was no patient involvement or injury reported.No other information provided with this complaint.

Manufacturer Narrative

(b)(4).Since the serial number is unknown, a device history review and service history search were not able to be completed.The investigation is in-process.If additional information becomes available, a supplemental report will be filed with the new information.File attachments.

Manufacturer Narrative

Evaluation summary: the screw on the us connector is loose and there is a gap, causing a leak.Correction information: g4: premarket identification pma/510(k) 510k number is not applicable.H6: coding changed based on the investigation result.Additional information: d9: device available for evaluation.

• Brand Name: PENTAX
• Type of Device: DIGITAL RADIAL ULTRASOUND SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX; 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: 13015105
• MDR Text Key: 284171222
• Report Number: 9610877-2021-01676
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: EG36-J10UR
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 12/08/2022
• 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