COUPLER
Received Sep 23, 2025
Report 1416980-2025-04734 · MDR key 23121621
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NICatalog number
NI
Lot number
NI
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
DURING A SURVEY, AN UNSPECIFIED HEALTHCARE WORKER RESPONDED ¿<80%¿ FLAP SURVIVAL RATE IN THE PAST 12 MONTHS WHEREIN A COUPLER WAS UTILIZED FOR AN UNSPECIFIED REASON DURING AN UNSPECIFIED PROCEDURE. THE RESPONDENT ADDITIONALLY STATED, ¿IT HAS BEEN A POSITIVE EXPERIENCE.¿ THESE EVENTS LIKELY REQUIRED MEDICAL INTERVENTION IN ORDER TO PRECLUDE PERMANENT IMPAIRMENT. THE RESPONDENT ANSWERED ANONYMOUSLY; THEREFORE, FOLLOW UP INFORMATION WAS NOT ABLE TO BE OBTAINED. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
H11: THE DEVICE WAS NOT RETURNED, AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.