MAUDE Adverse Event Report: PETER LAZIC GMBH MICROSURGICAL INNOVATIONS D-ANEURYSM MINI CLIP TITANIUM PERMANENT; CLIP, ANEURYSM

Model Number	S.35.714
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case is currently being investigated.
Event or Problem Description
Our customer has informed us that when the doctor opened the box of s.35.714, there was a product that did not match the catalog specifications.It supposed to be a strong curve, but the product in the box had a weak curve.Would you please let us know the cause of the problem and measures tp prevent future reoccurrences.

• Brand Name: D-ANEURYSM MINI CLIP TITANIUM PERMANENT
• Common Device Name: CLIP, ANEURYSM
• Manufacturer (Section D): PETER LAZIC GMBH MICROSURGICAL INNOVATIONS; immelmannweg 2; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer Contact: kim maier-zimmermann ; immelmannweg 2; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• MDR Report Key: 19069645
• Report Number: 8010890-2024-00001
• Device Sequence Number: 15195229
• Product Code: HCH
• UDI-Device Identifier: 04250603731665
• UDI-Public: 04250603731665
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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
• Device Model Number: S.35.714
• Device Catalogue Number: S.35.714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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