MAUDE Adverse Event Report: COVIDIEN MAX GR 5X18 T5 2/0 DT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 8886622953

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to report: supracervical hysterectomy with a and p repair being done when tip of needle broke off and unable to be recovered.

• Brand Name: MAX GR 5X18 T5 2/0 DT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6339362
• MDR Text Key: 67695258
• Report Number: 9612501-2017-00274
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: K990951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 8886622953
• Device Catalogue Number: 8886622953
• Device Lot Number: D6C1919X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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
• Patient Outcome(s): Other