MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.; LIGATURE CLIPS MULTI-FIRE

Model Number PL579T

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Intra-operative clip function deviation.During a prostatectomy with robot some of the clips bent and didn't hold on to the tissues.Applier reported below.Challenger ti-p handle_product (b)(4) & shaft compl.D:10mm l:370mm_product (b)(4).

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the received clips have several bruises on the surface and they are severely deformed.The clips were analyzed by microscope.Attempts to recreate the complaint were made; in order to get the described error, the applicator had to be rotated approximately 90 degrees before or during the application progress.This resulted in parts of the jaw being pushed apart, which severly deformed the ligature clip.A review of the device quality and manufacturing history records was not possible, as the lot number is unknown.Based on the information available as well as a result of the investigation, the root cause of the failure is most likely user related.Corrective / preventive action(s) is not necessary.

• Brand Name: CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.
• Type of Device: LIGATURE CLIPS MULTI-FIRE
• 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: 5114964
• MDR Text Key: 27176800
• Report Number: 2916714-2015-00844
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2015

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
• Device Operator: Health Professional
• Device Model Number: PL579T
• Device Catalogue Number: PL579T
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/09/2015
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other