MAUDE Adverse Event Report: W.O.M. - WORLD OF MEDICINE AIRSEAL 8MM ACCESS PORT AND LOW PROFILE OBTURATOR WITH BLADELESS OPTICAL TIP

Catalog Number IAS-120LP

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

The reported device was returned to conmed for evaluation.Visual inspection of the device in comparison with the active drawing determined the duck bill was detached from the sound reduction cap.This duck bill also showed signs of damage.This observed damage is likely a result of excessive force applied to the devices duck bill.(b)(4).A review of manufacturing documents and lot history was unable to be performed as the lot number was not provided by the facility.The instructions for use advise the user of the following: inspect sound cap blue foam and blue seal prior to use.Use caution when inserting a sharp or large device through the cannula.Inspect the sound cap after use for physical damage of any kind.This incident type will continue to be monitored through the complaint system to assure patient safety.

Event Description

A user facility reported that during a robotic hysterectomy, the seal in the silencer cap dislodged into the patient.The cap was retrieved and the procedure was completed as intended.The conmed sales representative stated this cap dislodged while a clip applier was being used.The report is raised on the basis of a reported device malfunction with potential for injury with recurrence.

• Brand Name: AIRSEAL 8MM ACCESS PORT AND LOW PROFILE OBTURATOR WITH BLADELESS OPTICAL TIP
• Type of Device: AIRSEAL
• Manufacturer (Section D): W.O.M. - WORLD OF MEDICINE; 4531 36th st; orlando FL 32811
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502
• Manufacturer Contact: lindsey sheppard ; 525 french road; utica, NY 13502 ; 7273995209
• MDR Report Key: 7096331
• MDR Text Key: 95081052
• Report Number: 3006217371-2017-00271
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/07/2017

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 Catalogue Number: IAS-120LP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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