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

Model Number	IAS12-120LPI
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
At the end of the procedure, doctor was removing the airseal trocar from the abdomen.A small part of the tip broke off.Doctor retrieved the part that broke off and removed the trocar.Pre-op diagnosis: grade 2 endometrial cancer, multiple prior abdominal surgeries.Post op diagnosis: grade 2 endometrial cancer, multiple prior abdominal surgeries.Procedure performed: robotic assisted total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, sentinel node mapping and excision, lysis of adhesions x 30 minutes procedure: it was noted that the suprapubic 12 mm airseal port was damaged with a small jagged edge at the intraperitoneal tip of the trocar.This had not been in contact with the intraperitoneal contents during the surgery.The abdomen was re-insufflated, and the colon and loops of terminal ileum in the pelvis were examined and no injuries were appreciated.The remaining ports were removed.

• Brand Name: AIRSEAL
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 6455 s yosemite st ste 1000; greenwood village CO 80111
• MDR Report Key: 11010549
• Report Number: 11010549
• Device Sequence Number: 870220
• Product Code: GCJ
• UDI-Device Identifier: 10845854045688
• UDI-Public: (01)10845854045688(17)230827(10)202008274
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2020
• Report Date (Section F): 12/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: IAS12-120LPI
• Device Catalogue Number: IAS12-120LPI
• Device Lot Number: 202008274
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 53
• Date Report Sent to FDA: 12/02/2020