MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; BATTERY LIGHT SOURCE - LED

Model Number	BS-LL1
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number is unavailable.Evaluation summary it was caused due to the connection part failure in the scope.This report is being filed as part of the pentax backlog management plan.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.The fiber scope can't emit the light.Bs-ll1 can't ignite the light and it showed no battery.

• Brand Name: PENTAX
• Common Device Name: BATTERY LIGHT SOURCE - LED
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12257115
• Report Number: 9610877-2021-10511
• Device Sequence Number: 3590054
• Product Code: EOQ
• UDI-Device Identifier: 04961333227259
• UDI-Public: 04961333227259
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2021

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: BS-LL1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 07/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1