MAUDE Adverse Event Report: COVIDIEN LP MARYLAND JAW LAP (37CM); LIGASURE VESSEL SEALING SYSTEM

Model Number LF1737

Device Problems Energy Output To Patient Tissue Incorrect (1209); Material Protrusion/Extrusion (2979)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The sample has been requested but to date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that device did not seal a vessel and bleeding occurred during a laparoscopic pediatric urology procedure.The surgeon noted that the handle was squeezed on the last attempt to seal the vessel and the knife accidentally extended.The vessel was accidentally cut and the bleeding occurred.Blood loss was described as less than 500cc.Bleeding was controlled with clamps and a new ligasure device.No transfusion was need and the patient is fine.

• Brand Name: MARYLAND JAW LAP (37CM)
• Type of Device: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 6100714
• MDR Text Key: 59845179
• Report Number: 1717344-2016-01059
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF1737
• Device Catalogue Number: LF1737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• 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