MAUDE Adverse Event Report: AESCULAP AG & CO. KG YASARGIL TI PERM STD-CLIP STR 11MM

Model Number FT760T

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 01/24/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Clips slipped out 3-4 days post surgery.Revision surgery is necessary due to the slipped clip.

Manufacturer Narrative

U.S.Reporting agent notified on (b)(4) 2014.Manufacturing site eval: jaw is no longer opaque and no longer closes completely.Complete surface is severely scratched.Various pressure marks in the shank and spring range.Significant closing force drop of 173 g to 145g.Conclusion: the scratched surface and the pressure marks indicate a multiple use.The pressure marks in the shank suggest that the clip was slanted in the applying forceps.Improper treatment has caused the overloading of the clip and thus the spring and the clamping force is adversely affected.Such is delivery state can be ruled out at 100%.

• Brand Name: YASARGIL TI PERM STD-CLIP STR 11MM
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen DE 7 8532
• Manufacturer (Section G): AESCULAP AG & CO. KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3845507
• MDR Text Key: 4407546
• Report Number: 2916714-2014-00130
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT760T
• Device Catalogue Number: FT760T
• Device Lot Number: 51909695
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1