MAUDE Adverse Event Report: COVIDIEN LP MARYLAND JAW LAP (44CM); LIGASURE VESSEL SEALING SYSTEM

Model Number LF1744

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of initial report: 12/20/2016.Visual inspection of the lf1744 found insulation on shaft was damaged and missing.The device was activated ten times on simulated tissue with satisfactory results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The device was activated with the rotation knob in various positions to detect any problematic activation issues.The alleged incident could not be duplicated.The investigation found the device to function normally and within specifications.An additional failure was found during the investigation; the insulation on the tubing was found to have damage and was missing.The insulation showed damage to the tubing close to the jaws as if the device had been grasped with a tool.Bare metal was visible in one place.The investigation identified the root cause of the additional finding to be user mishandling.Manufacturing non-conformances were reviewed and no entries pertinent to the customer's report were noted.

Event Description

The customer reported that the device did not work when it was plugged into the generator.Another device was used to complete the case.Upon receipt for investigation and initial inspection it was discovered that a small section of insulation from the black tube on the shaft was damaged and exposing the metal on the tube.The damaged insulation was not returned.The customer was not sure of the location of the disengaged black tubing.

• Brand Name: MARYLAND JAW LAP (44CM)
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO
• Manufacturer Contact: sharon murphy ; 5920 longbow dr.; boulder, CO ; 2034925267
• MDR Report Key: 6191566
• MDR Text Key: 62905298
• Report Number: 1717344-2016-01185
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 61550059X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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
• Patient Outcome(s): Other