MAUDE Adverse Event Report: AESCULAP AG DS-SINGLE FIRE LAP.APPLIER SM 5/310MM; LIGATURE / VESSEL CLIPS

Model Number PL802R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/13/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: information has been requested at the clinic three times on condition on the patient.A review of the device quality and manufacturing history records was not possible because 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 probably related to an insufficient usage.

Event Description

Country of complaint: (b)(6).It was reported by the healthcare professional to the company sales representative "during the application of a clip on the vessel, the prongs of the jaw broke and a screw of the applier and some of its part, fell down in the toracic cavity.Foreign body were re-taken during the surgery - in particular the screw was re-taken at the end of the surgery.".

• Brand Name: DS-SINGLE FIRE LAP.APPLIER SM 5/310MM
• Type of Device: LIGATURE / VESSEL CLIPS
• 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: 7783195
• MDR Text Key: 117130484
• Report Number: 9610612-2018-00369
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL802R
• Device Catalogue Number: PL802R
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/16/2018
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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