MAUDE Adverse Event Report: AESCULAP AG DISP.SEALING UNIT FOR 5MM TROCARS; HANDHELD PRODUCTS & LIGATION

Model Number EK001SU

Device Problem Contamination (1120)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with ek001su - disp.Sealing unit for 5mm trocars.According to the complaint description, the ring-shaped foreign matter was found to have fallen into the patient's abdominal cavity after inserting the trocar.The foreign matter was removed and the surgery was continued.This case occured during a laparoscopic surgery.An additional medical intervention was necessary.Additional information was not provided.The adverse event is filed under aag reference: (b)(4).

• Brand Name: DISP.SEALING UNIT FOR 5MM TROCARS
• Type of Device: HANDHELD PRODUCTS & LIGATION
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 16326501
• MDR Text Key: 309072892
• Report Number: 9610612-2023-00031
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EK001SU
• Device Catalogue Number: EK001SU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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