MAUDE Adverse Event Report: INTEGRA YORK, PA INC. FORCEPS CEV830 BIPOLAR 250MM MONTUPET; PFM16

Catalog Number CEV830

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

The doctor was using the bipolar instrument and the inner cannula that houses the bipolar tips came out.On (b)(6)2017 customer reports the inner cannula that holds the tips of the bipolar slid out of the outer cannula during a resection of a laryngeal tumor.No harm to patient.

Manufacturer Narrative

On 7/18/2017 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - device returned in used condition, showing minimal wear and the inner cannula that houses the bipolar tip, came out.It is also noticed that the shaft of the instrument is bent.Without knowing how much pressure was on the tip when in use, the cause is undetermined.This type of damage is usually the result from improper usage.The complaint report is confirmed, device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: FORCEPS CEV830 BIPOLAR 250MM MONTUPET
• Type of Device: PFM16
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6703682
• MDR Text Key: 80030253
• Report Number: 2523190-2017-00071
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K993655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

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: CEV830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/11/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1