MAUDE Adverse Event Report: AESCULAP AG & CO. KG YASARGIL TI TEMP STD-CLIP STR 7MM

Model Number FT240T

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 02/06/2015

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).When the surgeon tried to release the clip from the forceps, blades of the clip were not closed completely.The surgeon changed the clip to another one, and then the operation was done without problem.

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going at manufacturing site.

• Brand Name: YASARGIL TI TEMP STD-CLIP STR 7MM
• Manufacturer (Section D): AESCULAP AG & CO. KG; tuttlingen ; GM
• Manufacturer (Section G): AESCULAP AG & CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4617994
• MDR Text Key: 5591355
• Report Number: 2916714-2015-00187
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT240T
• Device Catalogue Number: FT240T
• Date Manufacturer Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: No
• 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