MAUDE Adverse Event Report: AESCULAP AG YASARGIL PERM STD-CLIP SLT-CVD 13.7MM; ANEURYSM CLIP

Model Number FE782K

Device Problems Loose or Intermittent Connection (1371); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 07/31/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation is on-going.

Event Description

Country of complaint: (b)(6).Customer requesting review and confirmation of closing force of clips.It was reported that the closing force was too weak during bypass surgery; clip being temporarily used during the collection of graft.One surgery was referenced, however (4) fe762k and (2) fe782k were received for evaluation.Not reported which product(s) were used during mentioned surgery.Related to medwatch 2916714-2015-00901.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: reference code 2 x fe782k, 4 x fe762k.Device name yasargil clip std.Permanent.Serial number (b)(4) (fe782k), (b)(4) (fe762k).Batch number 51951441, 51989192 (fe782k).51807166 (fe762k).Manufacturing date 07/16/2013, 12/16/2013 (fe782k).01/18/2012 (fe762k).The products were analyzed by microscope.The products show incorrect jaw positions and gaps between the jaw parts.The device history report was reviewed to review the closing force at the time of release.The device quality and manufacturing history records were reviewed for all available lot numbers.The device history file has been checked and found to be according to specification valid at the time of production.Based on the information available as well as a result of the investigation, the root cause of the failure is most likely user related.According to the statement of the surgeon, these type of clips are for permanent use only.The incorrect position and the gap in the jaw is an indication that the jaw was opened more than once which may cause a deviation of the closing force.Closing force can not be guaranteed after several openings.This is clearly indicated in the ifu.Based on the investigation and the statistical analysis manufacturing errors and a design related root cause are excluded.Error is likely user related.No additional action is required.

• Brand Name: YASARGIL PERM STD-CLIP SLT-CVD 13.7MM
• Type of Device: ANEURYSM CLIP
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5140790
• MDR Text Key: 28329704
• Report Number: 2916714-2015-00902
• Device Sequence Number: 1
• Product Code: HCH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K833650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2023
• Device Model Number: FE782K
• Device Catalogue Number: FE782K
• Device Lot Number: 51951741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other