MAUDE Adverse Event Report: KATENA PRODUCTS INC. ROSEN CHOPPER; OPHTHALMIC SPATULA

Device Problem Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 08/20/2012

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned for evaluation nor was the specific device item number reported.Subject device named in the received motion did not identify specific product id numbers.Based on this, the subject device could be one of two katena devices or even a competitor's device with the "rosen" name.The two subject "rosen" devices have been in commercial distribution, by this manufacturer, since november 1993 & february 1995 respectively.A review of katena's rosen device manufacturing processes and quality control methods confirmed, no anomalies or changes that could adversely affect device safety or effectiveness.Examination of two representative sample rosen devices did not find any abnormalities that could cause product failure as reported.Review of manufacturers complaint handling system database no other adverse reportable events for this subject device.

Event Description

Report of legal motion indicates post cataract surgery on (b)(6) 2016 a 1mm metal flake was observed in sub-incisional iris.Patient required an mri for other medical issues and there was concern for the metal flake in the iris.Based on this, subsequent surgical intervention, to remove foreign body, was performed but, not successful in that the metal fragment was firmly adherent to the iris and surgeon was concerned forcible removal could disinsert the iris.Surgeon reported he did not believe this foreign body would be a risk for movement during an mri and that removal would involve cutting iris tissue, which he did not think was justified given the low risk.

• Brand Name: ROSEN CHOPPER
• Type of Device: OPHTHALMIC SPATULA
• Manufacturer (Section D): KATENA PRODUCTS INC.; 4 stewart court; denville 07834
• Manufacturer (Section G): KATENA PRODUCTS INC; 4 stewart court; denville NJ 07834
• Manufacturer Contact: bryan weinmann ; 4 stewart court; denville, NJ 07834 ; 9739891600
• MDR Report Key: 5951186
• MDR Text Key: 54749624
• Report Number: 2242450-2016-00002
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR