MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L

Model Number EG-2990I

Device Problem Mechanical Problem (1384)

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

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

We checked the returned unit and confirmed that the nozzle gluing missing.Based on the result, we concluded that it was caused due to the physical damage applied on the nozzle gluing.In addition, we confirmed that the light guide fiber bundle (lcb) broken, and the remote control button cracked; however, they are not the main cause, and/or irrelevant to the alleged complaint.As a result of confirming the detail as gfe, no response was obtained, so we cannot deny the possibility of the glue falls.Therefore, based on the technical report "hr-rpt-0585 (nozzle)" and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is unknown.There was no report of patient harm.Air/water nozzle peeled off (black glue).

• Brand Name: PENTAX
• Type of Device: HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 14796504
• MDR Text Key: 303069568
• Report Number: 9610877-2022-54379
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333129492
• UDI-Public: 04961333129492
• 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: Physician
• Type of Report: Initial
• Report Date: 06/24/2022

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-2990I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/24/2022
• 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