MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 'PARSON' SIDE SLOTTED LARYNGOSCOPE, SIZE 2; Laryngoscope, Nasopharyngoscope

Model Number	8576D
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We learned from the hospital that their biomedical engineer tested our 8576d laryngoscope and our 10101ja prismatic light deflector used for the procedure with the welch allen light source that was also used in the procedure and found that the laryngscope became hot; however, when they tested our instruments using a pilling light source, they found no problem.The customer did not know what settings were used on the welch allen light source either during the procedure or for their testing.We advised the customer that it shouldn't matter what light source is used and that we recommend to always start at the lowest setting and gradually increase the light output.Customer advised that the patient is doing fine but that he has a scar.No product was returned for evaluation.
Event or Problem Description
Allegedly, during an anterior laryngeal web lysis procedure, the patient received a second degree burn to the lower lip.The patient was admitted for three days for pain control and feeding intolerance.
Additional Manufacturer Narrative
I made the correction in section h1, "serious injury" should be checked.This event is filed under internal complaint (b)(4).

• Brand Name: 'PARSON' SIDE SLOTTED LARYNGOSCOPE, SIZE 2
• Common Device Name: Laryngoscope, Nasopharyngoscope
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245--501 ; 4242188201
• MDR Report Key: 8026809
• Report Number: 9610617-2018-00089
• Device Sequence Number: 16489328
• Product Code: EQN
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K252624
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 8576D
• Device Catalogue Number: 8576D
• Device Lot Number: TS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 09/04/2026; 09/16/2026
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 09/17/2026; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability
• Patient Age: 3 YR
• Patient Sex: Male