MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C

Model Number EG-3870UTK

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

International medical device regulators forum (imdrf) adverse event reporting health effect clinical code: (b)(4) insufficient information.Health effect impact code: (b)(4) insufficient information.Medical device problem code: (b)(4) loose or imtermittent connection, (b)(4) fluid leak.Component code: (b)(4) connector/coupler.Type of investigation: (b)(4) type of investigation not yet determined.Investigation findings: (b)(4) no findings available.Investigation conclusions: (b)(4) conclusion not yet available.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint form the emea region.The information provided indicated that the probe is leaking on a pentax medical ultrasound video gastroscope model eg-3870utk, serial number (b)(4).An image was attached that depicts bubbles exiting the probe.The issue was observed in the workshop during inspection, after the customer sent the device in to be evaluated for a leak.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C
• 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: 12338709
• MDR Text Key: 268068669
• Report Number: 9610877-2021-00522
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2021

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-3870UTK
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1