MAUDE Adverse Event Report: AESCULAP AG SUSI METZENBAUM SCISSORS CVD.180MM; SUSI SINGLE USE SURGICAL INSTR

Model Number BC606SU

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient year of birth: (b)(6).Intra-operative medical intervention was necessary.The pair of scissors is broken at the hinge.Due to the defection with helipur, the surface of the instrument turned green.Vigilance investigation carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.According to the "intended purpose", this kind of scissors must be used for cutting, preparation of tissue, organs and other medical auxiliary materials.The device quality and manufacturing history records have been checked for the available lot number and found to be according to our 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.A capa is not necessary.

Event Description

It was reported by the healthcare professional "during an operational procedure of a mini thoracotomy to insert a thoracic drainage, the two eyes of the scissors were pulled together in order to bluntly widen the opening in the pleura by spreading the scissor blades.The scissors broke into three parts, which resulted in a 3cm long fragment of one of the scissor blades to remain in the chest of the patient.After a prolonged time in surgery the grasp of the scissor fragment was removed with tweezers from the patient's chest cavity." no direct physical damage to the patient.

• Brand Name: SUSI METZENBAUM SCISSORS CVD.180MM
• Type of Device: SUSI SINGLE USE SURGICAL INSTR
• 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: 8080332
• MDR Text Key: 127534702
• Report Number: 9610612-2018-00510
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC606SU
• Device Catalogue Number: BC606SU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/26/2018
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR