MAUDE Adverse Event Report: AESCULAP AG DISP.TROCAR THRD.W.DILATING PIN 12/110MM

Model Number EK236SU

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

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

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a trocar broke during a surgical procedure and a fragment went into the surgical site.The patient was taken for x-ray to determine the location of the fragment; however, retention of the broken piece was not confirmed by the x-ray that was performed.Additional information received on (b)(6) 2018: according pharmacist information, after the incident, a chest plate and x-rays were taken of the patient, but the part of the medical device was not found.The medical board met and the specialist recommended surgical intervention, however the doctor in charge decided to discharged with control on 10 days and alarm signs.Doctor in charge decided not to complete the revision surgery due to the risk.After 10 days patient did not report any inconvenience.A new review at 30 days indicated the patient was not experiencing any issues, no damage reported.

• Brand Name: DISP.TROCAR THRD.W.DILATING PIN 12/110MM
• Type of Device: TROCAR
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlinggen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlinggen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7928175
• MDR Text Key: 122447350
• Report Number: 9610612-2018-00452
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K101937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2018

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 Expiration Date: 02/28/2023
• Device Model Number: EK236SU
• Device Catalogue Number: EK236SU
• Device Lot Number: 52414832
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/27/2018
• Device Age: 5 MO
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2018
• 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
• Patient Outcome(s): Required Intervention