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

Model Number VNL11-J10

Device Problems Fluid/Blood Leak (1250); Material Invagination (1336)

Patient Problem Pain (1994)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Comments: failed dry and wet leak test.Hole resides on the rubber tubing closest to the scope handle itself.At the distal most end of the insertion tube, the rubber started to bunch up causing a slight mushrooming of the rubber.Patients report pain and scope was taken out of service.Potential adverse event.The time of event is unknown.Date of event is unknown.

Manufacturer Narrative

Evaluation summary.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information b4: date of this report g6: follow up #1 h2:if follow-up, what type? h3:device evaluated by manufacture h6: coding changed based on the investigation result additional information d9:device available for evaluation? e1:name and address h4:device manufacture date evaluation summary the customer owned endoscope was received by pentax medical for evaluation on 01-apr-2022.The endoscope was inspected by pentax medical service under work order (b)(4) and the service technician was able to confirm the customer complaint and documented the following inspection findings: scope leak test : dry leak test fail, scope electrical test function: dst electrical safety test fail, scope electrical test function: plct electrical safety test fail, insertion flexible tube: crushed, insertion flexible tube: fluid damage, insertion flexible tube: leak, insertion flexible tube: perforated, bending rubber: worn out, root brace rubber (insertion flexible tube): cracked, remote control button(1): cut, control body: fluid damage, control body: corroded, u/d knob: broken.The endoscope was repaired and the work order was closed on 28-apr-2022 and was delivered to the customer.A device history record(dhr) review for model vnl11-j10, serial number (b)(6) was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured in the miyagi facility on 12-dec-2018 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed for 12-dec-2018.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO ENT SCOPE
• 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 ; 8004315880
• MDR Report Key: 14139676
• MDR Text Key: 289503412
• Report Number: 9610877-2022-00482
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333221325
• UDI-Public: 04961333221325
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VNL11-J10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other