MAUDE Adverse Event Report: CONMED LINVATEC SST FORCEPS, SCOOP, STRAIGHT, 2.75MM X 130MM; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 2.1004

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The sst forceps evaluation is in process.A follow-up submission will be filed once the evaluation has been completed.

Event Description

It was reported by a nurse at the user facility that approximately 9 months ago, while the sst forceps were being used in surgery, the tip of the forceps broke and fell into the incision.The broken portion of the forceps was retrieved and the surgery completed with no injury to the patient.

Manufacturer Narrative

The broken sst forceps was received for evaluation on 01/13/2016.Visual inspection confirmed the customer's report.The lower cutter was broken off.Additionally, the actuator was worn, the etching was discolored, and the instrument would not function.Based on the condition and age of this device; this reported breakage event was the result of excessive usage and general wear and tear.The tip/cutter, tube and actuator were replaced, the handle was refurbished, and the device has been returned to the customer.This device was manufactured on 29-jul-2004.This device is over twelve (12) years old.Extended use and handling of the device can cause wear, damage and/or breakage to the forceps.A review of the service history shows there have been no previous repairs or maintenance performed on this instrument.A review of complaint history shows there have been no previous complaints reported on this device.The product insert that accompanies this device provides the following precautions: inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect instrument after use to ensure it has not been damaged.

• Brand Name: SST FORCEPS, SCOOP, STRAIGHT, 2.75MM X 130MM
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5440594
• MDR Text Key: 38998594
• Report Number: 1017294-2016-00010
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2.1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other