INTERFACE 8252800 RESPONSE 2.0 INCREMENT
Report
- Report Number
- 1045254-2012-00156
- Event Type
- Malfunction
- Date Received
- April 11, 2012
- Report Date
- March 16, 2012
- Manufacturer
- XOMED MFG JACKSONVILLE
- Product Code
- ETN
- PMA / PMN Number
- K024316
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
NO EVENT DATE PROVIDED. (B)(4). ANALYSIS BY THE QUALITY ENGINEER - THE PATIENT INTERFACE "CABLE CONNECTOR PINS WERE TWISTED." THIS IS A RISK RELATED TO AN ELECTRICAL OPEN RESULTING IN STIMULUS CURRENT NOT BEING DELIVERED AND BENT PINS RESULTING IN INTERMITTENT READINGS. NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. NEITHER APPLICABLE IMAGING FILMS, NOR WERE MEDICAL RECORDS RETURNED TO THE MANUFACTURER FOR EVALUATION. THIS DEVICE WAS OUT OF SPECIFICATION IN AN "AS RECEIVED CONDITION". THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. WITHOUT INFORMATION TO REASONABLY SUGGEST A SERIOUS INJURY OR MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. DEVICE DESCRIPTION: THE NIM-RESPONSE 2.0 IS A FOUR-CHANNEL EMG MONITOR FOR INTRAOPERATIVE USE DURING SURGERIES IN WHICH A MOTOR NERVE IS AT RISK DUE TO UNINTENTIONAL MANIPULATION. THE NIM-RESPONSE 2.0 RECORDS ELECTROMYOGRAPHIC (EMG) ACTIVITY FROM MUSCLES INNERVATED BY THE AFFECTED NERVE. THE MONITOR WILL ASSIST EARLY NERVE IDENTIFICATION BY PROVIDING THE SURGEON WITH A TOOL TO HELP LOCATE AND IDENTIFY THE PARTICULAR NERVE AT RISK WITHIN THE SURGICAL FIELD. IT WILL CONTINUOUSLY MONITOR EMG ACTIVITY FROM THE MUSCLES INNERVATED BY THE NERVE AT RISK TO MINIMIZE TRAUMA BY ALERTING THE SURGEON WHEN A PARTICULAR NERVE HAS BEEN ACTIVATED. THIS DEVICE IS INTENDED FOR USE IN SURGICAL PROCEDURES FOR PATIENT-CONNECTED INTRAOPERATIVE NERVE MONITORING, I.E. ASSISTING THE SURGEON IN LOCATING AND MAPPING MOTOR NERVES THROUGH THE USE OF ELECTROMYOGRAPHIC (EMG) SIGNALS AND ELECTRICAL STIMULUS OF NERVES. THE PATIENT INTERFACE AND CABLE PROVIDE THE MEANS FOR CARRYING ELECTROMYOGRAPHIC ACTIVITY FROM THE PATIENT'S INNERVATED MUSCLES TO THE CONSOLE, AN INTERFACE FOR CARRYING STIMULATION SIGNALS FROM THE CONSOLE TO THE STIMULATING PROBES/ELECTRODES, AND AN INTERFACE TO THE CONSOLE FROM THE INCREMENTING PROBE. THE PATIENT INTERFACE HAS FOUR OR EIGHT COLOR CODED PAIRS OF PATIENT ELECTRODE JACKS, A PATIENT ELECTRODE THIS DEVICE IS INDICATED FOR LOCATING AND IDENTIFYING CRANIAL AND PERIPHERAL MOTOR NERVES DURING SURGERY. THE INDICATIONS FOR USE STATES: THE NIM-RESPONSE 2.0 DOES NOT PREVENT THE SURGICAL SEVERING OF NERVES. IF MONITORING IS COMPROMISED, THE SURGICAL PRACTITIONER MUST RELY ON ALTERNATE METHODS, OR SURGICAL SKILLS, EXPERIENCE, AND ANATOMICAL KNOWLEDGE TO PREVENT DAMAGE TO NERVES.
THIS PRODUCT WAS RETURNED TO THE MANUFACTURER WITH A COMPLAINT OF "WILL NOT STIMULATE". THERE WAS NO ALLEGATION OF PATIENT INJURY OR REQUIRED INTERVENTION. MULTIPLE ATTEMPTS WERE MADE TO GAIN INFORMATION, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERFACE 8252800 RESPONSE 2.0 INCREMENT | STIMULATOR, NERVE | ETN | XOMED MFG JACKSONVILLE | 8252800 | 53352400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |