MAUDE Adverse Event Report: PETER LAZIC GMBH MICROSURGICAL INNOVATIONS LAZIC; CUSHING-LANDOLT SPECULA

Model Number	70.581.01
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The incident happened on (b)(6) 2023.Feedback that the incident occurred was received by peter lazic gmbh on (b)(6) 2023.The incident happened in a hospital in germany.The hospital states that the speculum was inserted into the right side of the nose and spread open.After completion of the procedure, the spreader could not be twisted back together, so it had to be removed in a wide open state.The hospital states that it could have led to a serious deterioration of the patient's health.The investigation of the cause is on-going.No patient data or further data on the procedure are known.Internal identification number (b)(4).

• Brand Name: LAZIC
• Common Device Name: CUSHING-LANDOLT SPECULA
• Manufacturer (Section D): PETER LAZIC GMBH MICROSURGICAL INNOVATIONS; immelmannweg 2; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer Contact: kim maier ; immelmannweg 2; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• MDR Report Key: 18353295
• Report Number: 8010890-2023-00001
• Device Sequence Number: 8489040
• Product Code: KAG
• UDI-Device Identifier: 04250603738718
• UDI-Public: 04250603738718
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2023

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: 70.581.01
• Device Catalogue Number: 70.581.01
• Device Lot Number: U043613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown