MAUDE Adverse Event Report: UNKNOWN 12MM AIRSEAL TROCAR ACCESSORY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Prolapse (2475); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The reported event was as follows: a clinical journal article cited that a 71-year-old male patient had undergone a robot-assisted radical prostatectomy.There was a brief dislodgement of a third party 12- mm airseal? trocar.Forty-eight hours after the procedure, diagnostic testing revealed an intestinal prolapse at the 12-mm airseal? trocar site.The patient was diagnosed with a strangulated bowel due to a trocar site hernia.An emergency exploration surgical procedure was performed where intestine was resected and an end-to-end anastomosis was performed.Pr (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 12MM AIRSEAL TROCAR ACCESSORY
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17530215
• MDR Text Key: 321131033
• Report Number: MW5137135
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1