MAUDE Adverse Event Report: AESCULAP AG TC MAYO-LEXER SCISSORS CVD 165MM; DUROTIP SCISSORS

Model Number BC284R

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The instrument is not available for investigation.The product does not require batch management; a review of the device quality and manufacturing history records is not possible.No product available and therefore it is not possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.Due to a lack of data and without the product not determine the exact cause.There is the possibility for a usage error due to a mechanical overload situation.If further investigations are required, the product should be provided for examination.

Event Description

During a surgical procedure a piece from the surgical instrument broke off at the outer edge of the chisel.The piece measures about 1mm long and about 0.5mm wide.At the time of the surgery, particles fell in the patient's scar.Medical device fragments remained in the patient.When additional information is received a follow up report will be submitted.

• Brand Name: TC MAYO-LEXER SCISSORS CVD 165MM
• Type of Device: DUROTIP SCISSORS
• 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: 8226410
• MDR Text Key: 132362484
• Report Number: 9610612-2019-00006
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC284R
• Device Catalogue Number: BC284R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/21/2018
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 30 YR
• Patient Weight: 49