MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE - I10 SLIM

Model Number EG27-I10

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

The endoscope was inspected by pentax medical service and the technician confirmed hole at the primary channel distal body connection: air/water nozzle glue missing, passed dry leak test, passed wet leak test, suction tube resistance, right/left and up/down angle wires short, umbilical cable coil shifting and control body boot brace cut.The scope was cleaned and disinfected, angulation was adjusted, and the video image calibrated.The endoscope was approval by final qc on 30-aug-2021 and returned to the customer.If additional information is received, a supplemental report will be submitted.

Event Description

Pentax medical was made aware that during a pai service inspection, the technician noticed a primary operation channel hole at the distal body connection on an eg27-i10 (sn: (b)(4)) video upper g.I.Scope.No serious injury or death of a patient or user, or delay in a procedure which would require medical intervention was reported.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE - I10 SLIM
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12712050
• MDR Text Key: 284363378
• Report Number: 9610877-2021-01021
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333186846
• UDI-Public: 04961333186846
• Combination Product (y/n): N
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG27-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1