MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO LARYNGOSTROBOSCOPE (SLIM)

Model Number	VLS-1070STK
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pentax model vls-1190stk is classified as exempt, therefore 510k is not applicable.(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Pentax medical became aware of a report for an event which occurred in the united states stating, " no video image" involving pentax model vls-1070stk, serial number (b)(4).The event was reported to occur in the operating room, before use.There was no report of death, serious injury or other significant/important medical event.The customer owned endoscope was received by pentax medical for evaluation on 30-jul-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician confirmed the customer complaint of image blackout and also documented the following inspection findings: insertion tube severe crush at stage 1, passed wet leak test, long umbilical cable buckle at junction, long umbilical cable crush, passed dry leak test, short umbilical cable buckle at umbilical connector side, short umbilical cable crush, light carrying bundle has less than 70% transmission, # 4 remote control button cover cracked, hole in # 1 remote control button cover, insertion tube severe crush at stage 2, insertion tube severe crush at stage 3.The device underwent repairs including the following components: o-rings and seals, distal end w/ccd-m pb-free/ntsc, insertion flex tube w/seg pb-free, bending rubber, segment steel braid, distal attaching pin, remote control button(1)pb_free, r.C.Button (4) pb-free, light guide cable for connector, light guide cable long.The endoscope was approved by final qc on 24-aug-2021 and was delivered to the customer under delivery order (b)(4).Model vls-1070stk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.

• Brand Name: PENTAX
• Common Device Name: VIDEO LARYNGOSTROBOSCOPE (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: 12377806
• Report Number: 9610877-2021-00551
• Device Sequence Number: 4407299
• Product Code: EQL
• UDI-Device Identifier: 04961333240371
• UDI-Public: 04961333240371
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: REFER TO H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VLS-1070STK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1