MAUDE Adverse Event Report: PETER LAZIC GMBH MICROSURGICAL INNOVATIONS D-CLIP STANDARD/MINI APPLIER/REMOVER; APPLIER, ANEURYSM CLIP

Model Number	35.421
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case is currently being investigated.
Event or Problem Description
Our customer has informed us that the applier remains jammed.The applier does not release clips.

• Brand Name: D-CLIP STANDARD/MINI APPLIER/REMOVER
• Common Device Name: APPLIER, ANEURYSM CLIP
• 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: 19094762
• Report Number: 8010890-2024-00002
• Device Sequence Number: 15407067
• Product Code: HCI
• UDI-Device Identifier: 04250603739630
• UDI-Public: 04250603739630
• 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): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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?: No
• Device Model Number: 35.421
• Device Catalogue Number: 35.421
• Device Lot Number: X591938
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (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