FDA Adverse Event Malfunction Summary report: N

PENTAX

MDR report key: 12764323 · Received November 7, 2021

Report

Report Number: 9610877-2021-01452
Event Type: Malfunction
Date Received: November 7, 2021
Date of Event: October 27, 2021
Report Date: December 17, 2021
Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE
Product Code: FDT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

EVALUATION SUMMARY: THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL ED34-I10T-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K163614. WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE OBJECTIVE PRISM IS BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE OBJECTIVE PRISM. IN ADDITION, WE CONFIRMED THAT THE LCB DISTAL COVER GLASS WAS BROKEN; HOWEVER, IT IS NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR. CORRECTION INFORMATION: G6: FOLLOW UP #1. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

Additional Manufacturer Narrative · 0

THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE (B)(6) 510K IS NOT APPLICABLE. MODEL ED34-I10T-US IS AVAILABLE IN THE USA WITH A 510K NUMBER K163614. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

Description of Event or Problem · 0

OP-CHANNEL IS CLOGGED, THERE ARE TWO ACCESSORIES INSIDE. THE TIME OF EVENT IS REPROCESSING. THERE WAS NO REPORT OF PATIENT HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1654665	PENTAX	VIDEO DUODENOSCOPE - I10 STANDARD	FDT	HOYA CORPORATION PENTAX TOKYO OFFICE	ED34-I10T

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown