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U.S. Department of Health and Human Services

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

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CONMED CORPORATION AIRSEAL LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number IAS12-120LPI
Device Problems Detachment of Device or Device Component (2907); Tip (3123)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2020
Event Type  Malfunction  
Event Description

An 8 mm plastic chip had broke off the tip of the airseal trocar during robotic surgery. Tip was unable to be located and removed from within the surgical site. Fda safety report id# (b)(4).

 
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Brand NameAIRSEAL
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
CONMED CORPORATION
MDR Report Key10167575
MDR Text Key195946724
Report NumberMW5095057
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberIAS12-120LPI
Device LOT Number82519
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/17/2020 Patient Sequence Number: 1
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