GRIESHABER DELAMINATION SPATULA DSP

Additional Manufacturer Narrative

NO LOT NUMBER WAS IDENTIFIED WITHIN THE SURVEY AND THEREFORE WITHIN THIS COMPLAINT, WHICH IS WHY THE ASSOCIATED MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED. ALL PRODUCT AND BATCH HISTORY RECORDS ARE QUALITY REVIEWED PRIOR TO PRODUCT RELEASE, ENSURING THAT ALL PRODUCTS ON THE MARKET FULFILL THE RELEVANT REQUIREMENTS. SINCE THE QUESTIONNAIRE RETROSPECTIVELY COLLECTED DATA, NO SAMPLE IS AVAILABLE TO BE PROVIDED TO THE RESPONSIBLE SITE FOR AN IN-DEPTH INVESTIGATION. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE IDENTIFIED. THE EXACT ROOT CAUSE FOR THE CUSTOMER¿S REPORTED EVENT IS UNKNOWN. THEREFORE, NO SPECIFIC ACTION CAN BE TAKEN. WITHIN THE FRAMEWORK OF THE MENTIONED NCI, AN OVERALL RISK ASSESSMENT WAS PERFORMED AND CONCLUDED THAT NO FURTHER ACTIONS ARE REQUIRED. ADDITIONALLY, COMPLAINTS ARE REVIEWED AND MONITORED AT REGULAR INTERVALS FOR ADVERSE TRENDS. NO ADDITIONAL ACTIONS ARE NEEDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW-UP STUDY INDICATED THAT THE FEMALE PATIENT UNDERWENT A VITRO RETINAL PROCEDURE USING A FINESSE FLEX LOOP AND DELAMINATION SPATULA AS A TREATMENT TO IMPROVE CURRENT VISION. THE PATIENT HAS EXPERIENCED HYPOTONY, INFLAMMATION AND LACERATION. PATIENT WAS HOSPITALIZED. CURRENT CONDITION OF PATIENT IS IMPROVING.