MAUDE Adverse Event Report: DAI-ICHI SHOMEI CO., LTD STELLAR SERIES; SURGICAL LIGHT ACCESSORY

Model Number ST2323

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

While reviewing the old mdrs, dai-ichi shomei (dkk) realized that two follow-up reports had been submitted without initial reports.Further, the same report number 3006437518-2018-00001 was erroneously assinged to the two follow-up reports.Dkk submitted an initial report for one of the follow-up reports with the report number 3006437518-2018-00001 and submitted this initial report for the other follow-up report.To make a distinction, a new report number 3006437518-2020-00002 was assigned to this initial report.Dkk also made some corrections on the information provided in the follow-up report as following: brand name: changed to stellar series from skytron.Model #: changed to st2323 from b1-710-73.

Event Description

On september 4, 2015, dai-ichi shomei received information that during a procedure the acrylic cover and lens opened, and dust fell over the operative site from the surgical light.Dust did not enter the patient.

• Brand Name: STELLAR SERIES
• Type of Device: SURGICAL LIGHT ACCESSORY
• Manufacturer (Section D): DAI-ICHI SHOMEI CO., LTD; 32-26 sakashita; itabashi-ku, tokyo 174-0 043; JA 174-0043
• Manufacturer (Section G): DAI-ICHI SHOMEI CO., LTD; 32-26 sakashita; itabashi-ku, tokyo 174-0 043; JA 174-0043
• Manufacturer Contact: yoko yoshii ; 32-26 sakashita; itabashi-ku, tokyo 174-0-043 ; JA 174-0043
• MDR Report Key: 10165980
• MDR Text Key: 201839061
• Report Number: 3006437518-2020-00002
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST2323
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other