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

Model Number EG-3870UTK

Device Problem Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a complaint on 21-mar-2018 stating the following "the fna needle is not coming out the end of the scope properly" involving pentax video gastroscope ultrasound-linear array eg-3870utk/serial (b)(4).No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported by the user.On 21/mar/2018, pentax medical issue (b)(4) for the return of the unit for further evaluation.The unit was received at pentax medical service on 02/apr/2018 where it was inspected on 10/apr/2018.The inspector found the following: umbilical cable junction casing bottom cracked, prism scratched, elevator knob play, elevator washing socket cylinder rubber chipped, customer complaint not duplicated, failed wet leak test, lightguide prong cover glass set loose, failed dry leak test, leak at umbilical cable junction casing, umbilical cable single buckled under pve root brace, umbilical cable bump at pve side, insertion tube gauge/dig at stage 1, fluid invasion not observed in pve connector, fluid invasion not observed in control body, ultrasound image has broken channel, suction tube mild resistance.

• Brand Name: PENTAX
• Type of Device: ULTRASOUND 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: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 7447412
• MDR Text Key: 106983881
• Report Number: 9610877-2018-00117
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018,03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3870UTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2018
• Distributor Facility Aware Date: 03/21/2018
• Device Age: 84 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1