MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PRISMATIC LIGHT DEFLECTOR

Model Number	10101JA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This incident was deemed as an "adverse event".However we failed to file the importer medwatch, and therefore will submit the importer medwatch now retrospectively.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during a case on april-26-2024, the spring connector piece on the prismatic light deflector came apart and the 3 components had to be retrieved from the patient.No patient injury was reported.However it prolonged the case and they had to do an x-ray check on the patient to confirm they have retrieved all of the broken pieces from the patient.

• Brand Name: PRISMATIC LIGHT DEFLECTOR
• Common Device Name: PRISMATIC LIGHT DEFLECTOR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19785992
• Report Number: 2020550-2024-00146
• Device Sequence Number: 8068544
• Product Code: EOQ
• UDI-Device Identifier: 04048551045268
• UDI-Public: 4048551045268
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2024
• Report Date (Section F): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10101JA
• Device Catalogue Number: 10101JA
• Device Lot Number: WZ02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown