MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO CLOSE* TROCAR SITE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 173022

Device Problem Protective Measures Problem (3015)

Patient Problem Skin Tears (2516)

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a live donor nephrectomy, closing the abdominal wall ports using an endo close slipped and cut my left middle finger.Instrument disposed.Degloved, milked finger under running water.Hand washed using soap.Attended occ.Health and provided evidence of virology of patients take then day prior.It was a low risk patient and everything came back clear.Surgeon ok and no risk patient.

Event Description

Additional information received from the account: the patient undergoing the procedure was male.No age known but fairly young with a muscular abdominal wall.The medical professional that had the device issue was female.

• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5032079
• MDR Text Key: 25042705
• Report Number: 2647580-2015-00606
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K954853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 173022
• Device Catalogue Number: 173022
• Device Lot Number: P4J0269X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1