MAUDE Adverse Event Report: AESCULAP AG & CO. KG YASARGIL TI PERM MINI-CLIP BAYO 4MM; ANEURYSM CLIP

Model Number FT727T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).The surgeon placed the clip and made a puncture to dome.After placement it was noticed that the tip of the blade was slightly scissored.Clip was left in patient as is.

Manufacturer Narrative

Us reporting agent notified on 01/30/2015.Manufacturing site evaluation: we received no product, because the clip is still placed inside the patient.It could be possible, that the surgeon, due to an overload situation in the delicate jaw area a scissoring, had created.This product is 100% inspected during the final inspection.The blade alignment is inspected by a visual inspection.So we can exclude a manufacturing error.There are no other cases with "clip was left in patient with scissoring" in our system.Reviewed the manufacturing file of batch 52034072, the quality records as well as the production documents comply with our specifications and do not present any discrepancies.No other similar incidents have been declared concerning this batch.

• Brand Name: YASARGIL TI PERM MINI-CLIP BAYO 4MM
• Type of Device: ANEURYSM CLIP
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen ; DA
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4544163
• MDR Text Key: 16462073
• Report Number: 2916714-2015-00083
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K970050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT727T
• Device Catalogue Number: FT727T
• Device Lot Number: 52023072
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR