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

Model Number	35.411
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The incident occured in ecuador.Our distributor in ecuador has received the following information from his customer: the applier failed during surgery.The applier did not release the clip.The applier remained attached to the clip.The affected applier and all similar appliers with the article numbers 35.410, 35.411 and 35.412 are being removed from the market.These are all appliers with a rigid jaw.It is planned to redesign the jaw part of the applier to prevent the defect from recurring as far as possible.To this end, prototypes were produced and given to various doctors in order to obtain feedback on the redesign of the jaw parts.The patient was not injured.However, the incident could have led to a deterioration of the health.

• Brand Name: D-CLIP STANDARD/MINI ANLEGEZANGE
• 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: 19069584
• Report Number: 8010890-2023-00002
• Device Sequence Number: 4732547
• Product Code: HCI
• UDI-Device Identifier: 04250603739609
• UDI-Public: 04250603739609
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 35.411
• Device Catalogue Number: 35.411
• Device Lot Number: W591456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• 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: 11/02/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 93938
• Patient Sequence Number: 1
• Patient Sex: Unknown