MAUDE Adverse Event Report: INTEGRA YORK, PA INC. CARB-EDGE METZ SCS 9 CVD; CARDIOVASCULAR SCISSORS

Catalog Number 101267

Device Problem Break (1069)

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

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Fda sus voluntary event report mw5072008 reports that the metal tip of the surgical jarit carb edge scissor #101267 broke off during an abdominal surgical procedure x-ray were negative.

Manufacturer Narrative

On 10/24/17 integra investigation completed.Method: failure analysis, device history evaluation.Complaint is unconfirmed; this is due to the product not being returned for review.Device history evaluation - dhr review 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: none.Health hazard evaluation history: none.Root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

• Brand Name: CARB-EDGE METZ SCS 9 CVD
• Type of Device: CARDIOVASCULAR SCISSORS
• 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: 6967750
• MDR Text Key: 90891808
• Report Number: 2523190-2017-00100
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2017

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: 101267
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/22/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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