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

Model Number EG-2990I

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

The time of event is unknown.There was no report of patient harm.Biopsy inlet piece loosened.

Manufacturer Narrative

We checked the returned unit and confirmed that the biopsy inlet piece loosened.Based on the result, we concluded that it was caused due to the excessive force applied on the biopsy inlet piece.In addition, we confirmed that the bending rubber leaky, the remote control buttons cut, the air/water nozzle loosened, and the brand plate worn out; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0620(control body)"" and/or the risk analysis results, it was evaluated to submit mdr.

• 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; 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 ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 14184129
• MDR Text Key: 295699775
• Report Number: 9610877-2022-52914
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2022

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: 04/08/2022
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/22/2022
• 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