MAUDE Adverse Event Report: KARL STORZ SE & CO. KG PRISMATIC LIGHT DEFLECTOR; PRISMATIC LIGHT DEFLECTOR WITH FIBER OPTIC LIGHT CABLE

Model Number	10101JA
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned by the facility, therefore no evaluation findings are available.
Event or Problem Description
Per the facility, after a direct laryngoscopy with bronchoscopy while the in pacu the patient coughed up 3 small pieces from the light deflector.Per the or nurse no further intervention was required.

• Brand Name: PRISMATIC LIGHT DEFLECTOR
• Common Device Name: PRISMATIC LIGHT DEFLECTOR WITH FIBER OPTIC LIGHT CABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 11406332
• Report Number: 9610617-2021-00019
• Device Sequence Number: 4532391
• Product Code: EOQ
• UDI-Device Identifier: 04048551045268
• UDI-Public: 4048551045268
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K943700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10101JA
• Device Catalogue Number: 10101JA
• Device Lot Number: YQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2021
• 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: Required Intervention
• Patient Age: 12 YR