MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION CLIPS MULTI-FIRE TITANIUM

Model Number PL569T

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problems Excessive Tear Production (2235); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Temporary damage that will heal fully and will most likely not negatively influence the patient in the future.Visually, no deviation can be found on the provided components.The recommended maintenance date 02/2019 is labelled on the handle and all components of the shaft.Vigilance investigator carried out the pictorial documentation visually and microscopically.A functional test was carried out and the applied clips found to be uneven.The jaw parts of the shaft are slightly bent and no longer even, most likely caused by a leverage effect during handling or reprocessing, tilting in a reprocessing basket.Additional damages on the cartridge were found, pressure marks, most like caused by a forceps, a crack at the distal end and scratching marks.The cause of this damage is no longer traceable.Three clips remained in the cartridge.No deviations can be found on the handle.The device quality and manufacturing history records have been checked for the available lot number and found to be according to specifications valid at the time of production.No similar incidents have been filed with products from this batch.Based on the information available as well as a result of the investigation the root cause of the failure is most probably related to an insufficient usage.

Event Description

It was reported by the healthcare professional "io clip tore a hole in the cystic." all med watch submissions related to this patient are: 9610612-2019-00172, 9610612-2019-00173.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LIGATION CLIPS MULTI-FIRE TITANIUM
• 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
• MDR Report Key: 8421051
• MDR Text Key: 138807900
• Report Number: 9610612-2019-00174
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Device Lot Number: 52411202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/08/2019
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention