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

Model Number	EB-1570K
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
(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
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 owned endoscope was previously returned to pentax medical from a customer on 28-jun-2021.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician documented the following inspection findings on 29-jun-2021: suction arm loose, leak at biopsy channel (large/ primary) distal side, failed dry leak test, umbilical cable buckle at umbilical connector side, failed wet leak test, operation channel- primary mild resistance.Inspection of the suction arm was performed and the device failed the inspection criteria.The endoscope's repairs to be performed where the loose suction arm will be corrected, and the unit returned to inventory upon completion.Parts replaced: o-rings and seals, distal end assy with tube, distal joint screw m1, light guide cable, insertion/s-nipple attaching screw, o-ring(1.25x3.5), suction connection tube, o-ring(1.2x3.5), bending rubber.Pentax medical model eb-1570k, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on 06-nov-2009.The endoscope was repaired and approved by final qc on 26-jul-2021 and was delivered to the customer on under delivery order (b)(4).

• 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: 12246211
• Report Number: 9610877-2021-00413
• Device Sequence Number: 19957000
• Product Code: EOQ
• UDI-Device Identifier: 04961333228102
• UDI-Public: 04961333228102
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/29/2021

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-1570K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/29/2021
• 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