FDA Adverse Event Malfunction Summary report: N

ELECTRICAL REMOTE-CONTROLLED CLAMP 620MM

MDR report key: 18500785 · Received January 12, 2024

Report

Report Number: 9611109-2024-00029
Event Type: Malfunction
Date Received: January 12, 2024
Date of Event: December 14, 2023
Report Date: December 12, 2024
Manufacturer: LIVANOVA DEUTSCHLAND GMBH
Product Code: DTQ
PMA / PMN Number: K071318
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

THROUGHT FOLLOW UP LIVANOVA WAS INFORMED THE ERC CLAMP CORRECLY CLOSED FOLLOWING THE LEVEL/BUBBLE ALARM. THE ALARM DISPLAYED WAS INDICATING THE AUTO CLAMP IS MALFUNCTIONING. THE ERC WAS TAKEN OUT FROM SERVICE. LIVANOVA CONTINUING AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 0

H11. THROUGH FOLLOW UP LIVANOVA WAS INFORMED THE ERC WAS TAKEN OUT FROM SERVICE AND REPLACED AT THE CUSTOMER'S SITE. UNIT WAS SENT TO MANUFACTURER FOR REPAIR. NO EVIDENCE OF THE COMPLETION OF THE REPAIR ACTIVITY HAS BEEN MADE AVAILABLE. THE UNIT HAS BEEN INSTALLED SINCE 2014 AND THE ANALYSIS OF THE COMPLAINTS DATABASE DID NOT REVEAL FURTHER SIMILAR REPORTED INCIDENTS. TAKING INTO ACCOUNT REVIEW OF PREVIOUS SIMILAR CASES, THE ROOT CAUSE OF THE REPORTED ISSUE COULD BE TRACED BACK TO: MECHANICAL FAULT (BLOCKED CLAMP SPINDLE #60-05-13). DEFECTIVE HALL SENSORS LOCATED IN THE ERC STATOR #97-103-645. A DEFECTIVE ZKA #90-305-310 OR ZKB #90-305-320 BOARD. BASED ON THE ABOVE ELEMENTS, AN ISOLATED FAILURE OF THE AFOREMENTIONED COMPONENTS CANNOT BE RULED OUT AS THE ROOT CAUSE OF THE REPORTED ERROR MESSAGE. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 0

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE S5 ERC TUBING CLAMP. THE INCIDENT OCCURRED IN JAPAN. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Additional Manufacturer Narrative · 0

H11: THROUGH FOLLOW UP COMMUNICATION WITH LIVANOVA TECHNICIAN IN CHARGE, IT WAS LEARNED THAT THE PARTS REPLACED WAS INCORRECTLY COMMUNICATED. THE PARTS THAT WERE ACTUALLY REPLACED ON THE INVOLVED UNIT TO SOLVE THE ISSUE ARE THE FOLLOWING: - CLAMP SPINDLE; - ELECTRICAL REMOTE-CONTROLLED TUBING CLAMP (ERC) STATOR; - HOUSING REAR. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE UNIT HAS BEEN INSTALLED SINCE 2014 AND THE ANALYSIS OF THE COMPLAINTS DATABASE DID NOT REVEAL FURTHER SIMILAR REPORTED INCIDENTS. BASED ON TECHNICAL INTERVENTION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT HAS BEEN ASSIGNED TO A MECHANICAL FAILURE OF THE COMPLETE MOTOR BLOCK OF THE ERC.

Additional Manufacturer Narrative · 0

H11: THE AFFECTED PART WAS RETURNED TO LIVANOVA DEUTSCHLAND FOR A DETAILED INVESTIGATION. THE TECHNICIAN COULD CONFIRM AND REPRODUCE THE REPORTED ISSUE. BALL BEARINGS WERE REPLACED, ALSO TO PREVENT ISSUES RELATED TO FLUID INGRESS. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THEREFORE, IT CANNOT BE RULED OUT THAT THE ROOT CAUSE OF THE REPORTED MALFUNCTION WAS MOST LIKELY THE USE CONDITION (I.E. EXTENSIVE EXPOSURE TO LIQUID, E.G. DURING CLEANING) OVER TIME.