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

Model Number	EB-1970K
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International medical device regulators forum (imdrf) adverse event reporting (b)(4) no clinical signs, symptoms or conditions.(b)(4) no patient involvement.(b)(4) loose or intermitternt connection.(b)(4) nozzle.Type of investigation: 10 testing of actual/suspected device.Investigation findings: 140 wear problem.Investigation conclusions: 129 cause traced to device design.
Event or Problem Description
Pentax of america initiated field correction 2017-008-c which included inspection of the suction arm on affected models pursuant to predefined inspection criteria (qs-397).The objective of the inspection was to locate part c255-ab171 (suction arm) and verify it is not loose.If part c255-ab171 (suction arm) is found loose, the device was considered to fail the inspection criteria.The customer device was previously returned to pentax medical from a customer on (b)(6) 2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician documented the following inspection findings on (b)(6) 2021: suction arm loose, insertion tube severe crush at stage 2, distal body chip at channel opening at thinnest part, light carrying bundle has less than 70% transmission, leak at biopsy channel (large/ primary) distal side, failed wet leak test, up/ down brake lever non-pentax material, failed dry leak test, primary operation channel resistance, customer complaint confirmed, # 1 remote control button cover cracked, umbilical cable single mild discoloration, insertion tube mild crush at stage 1, insertion tube mild crush at stage 2, hole in # 4 remote control button cover, insertion tube root brace cut, inspection of the suction arm was performed and the device failed the inspection criteria.The scope's repairs to be performed where the loose suction arm will be corrected, and the unit returned to the user upon completion.Parts replaced: o-rings and seals, bending rubber, distal joint screw m1, light guide fiber bundle (lcb), distal joint screw m1, insertion flexible tube w/segment, remote control button(1)pb_free, r.C.Button (4) pb-free, friction lever assy, distal end assy with tube.This is the first time pentax model eb-1970k, serial number (b)(4) has been returned for serviced at a pentax facility since the device was put into service on (b)(6) 2005.

• Brand Name: PENTAX
• Common Device Name: VIDEO BRONCHOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12028187
• Report Number: 9610877-2021-00112
• Device Sequence Number: 4269178
• Product Code: EOQ
• UDI-Device Identifier: 04961333228133
• UDI-Public: 04961333228133
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131028
• 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: Non-Healthcare Professional
• Remedial Action: Recall,Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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: No Information
• Device Model Number: EB-1970K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT ISSUED YET
• Patient Sequence Number: 1