MAUDE Adverse Event Report: AESCULAP AG DISP.TROCARSLEEVE 5/110MM THREAD.W/O TAP; DISPOSABLE TROCARS

Model Number EK117SU

Device Problem Material Fragmentation (1261)

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

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: we received the complained trocar decontaminated by the customer and one original sealed trocar of the same lot for investigation.The distal end of the trocar is broken, the fragments are not available for investigation.Investigation was carried out visually and microscopically.Several tests have been performed.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 it is not possible to determine an exact root cause of the failure, it could be a manufacturing, a design related or a combination of multiple factors.An internal risk assessment and a capa have been performed.

Event Description

It was reported that there was an issue with disposable trocar sleeve.According to the complaint description: the trocar was used for a laparascopic rectal resection.At the bottom of the trocar sleeve splinters were broken off intraoperatively, which was only noticed when the surgery was finished and the trocar was removed.The search for the fragments was unsuccessful and due to the red color they were not easily visible.Surgeon estimates the risk of the pieces remaining in the patient to be low.The material edges were not sharp; the piece was approximately 3 x 3 mm.The broken fragment may have remained in situ.The malfunction is filed under aag reference (b)(4).

• Brand Name: DISP.TROCARSLEEVE 5/110MM THREAD.W/O TAP
• Type of Device: DISPOSABLE TROCARS
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8935740
• MDR Text Key: 155864395
• Report Number: 9610612-2019-00571
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: EK117SU
• Device Catalogue Number: EK117SU
• Device Lot Number: 52476787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• 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