MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL 12MM ACCESS PORT AND OBTURATOR WITH BLADELESS OPTICAL TIP, 100MM LENGTH; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number IAS12-100

Device Problems Component Falling (1105); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

As reported, the used/damaged airseal 12 mm access port is expected to be returned for evaluation.However, as of this filing the device has not yet been returned from the user facility.A supplemental and final report will be filed upon the completion of the product evaluation and complaint investigation.

Event Description

The user facility reported that during use of the airseal 12 mm access port in a robotic-assisted laparoscopic prostatectomy (ralp) on (b)(6) 2017, the blue rubber part of sound cap was torn and dropped into the patient's abdominal cavity.The broken piece was safely removed with no problems noted.The procedure was otherwise completed as planned with no patient injury or surgical delay reported.This report is filed on the basis of potential for patient injury with recurrence.

• Brand Name: AIRSEAL 12MM ACCESS PORT AND OBTURATOR WITH BLADELESS OPTICAL TIP, 100MM LENGTH
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): SEQUEL SPECIAL PRODUCTS; 122 avenue of industry; waterbury CT 06705
• Manufacturer Contact: n. kim grady ; 11311 concept boulevard; largo, FL 33773 ; 7273995479
• MDR Report Key: 6661755
• MDR Text Key: 78374887
• Report Number: 3006217371-2017-00015
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAS12-100
• Device Lot Number: 88516J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• 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: Unknown
• Patient Sequence Number: 1