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

Model Number EG-3485K

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pentax video gastroscope model eg-3485k is not distributed in the usa, therefore the pma/510(k) number is not applicable.

Event Description

Pentax medical became aware of a report for an event which occurred in the (b)(6) stating the rubber end piece was found in the patient's mouth.The staff are unsure if the patient bit the end of the endoscope during the procedure or the rubber end piece was not fitted correctly.No adverse events were reported to have occurred with the patient or user.The gastroscope was returned to the pentax service center in the (b)(4) for evaluation.The gastroscope, including the distal end, was inspected and found to be in good condition.The distal cap was not returned, therefore, no evaluation on the distal cap could be performed.The distal cap was replaced on the gastroscope.The ifu for this model gastroscope instructs the user to inspect the distal cap before use.The user reported this event to (b)(4).

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 7627105
• MDR Text Key: 112555991
• Report Number: 9610877-2018-00306
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2018,05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3485K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2018
• Distributor Facility Aware Date: 05/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2018
• Date Manufacturer Received: 05/22/2018
• 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