MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number IAS5-120LP

Device Problems Break (1069); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2023

Event Type  malfunction  

Event Description

Doctor was performing a robotic low interior resection in operating room while working laparoscopically.The air seal trocar was noted to be broken, trocar was removed from patient's abdomen and inspected.Upon inspection it was discovered that an extremely small clear piece of plastic approximately 2-3 mm was missing.Abdomen and sterile field were exhaustively searched with no results, the torcar was replaced and per protocol a stat wet read x-ray was performed at the end of the case.No foreign body was detected per doctor.Damaged trocar was placed in plastic bag with original packaging and patient label and placed in charge office.Manufacturer response for cannula, air seal (per site reporter).Awaiting qa.

• Brand Name: AIRSEAL
• Type of Device: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• MDR Report Key: 16385216
• MDR Text Key: 309654778
• Report Number: 16385216
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IAS5-120LP
• Device Catalogue Number: IAS5-120LP
• Device Lot Number: 202206174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Male