MalfunctionKOI

SMART CABLE NMT MODULE AND ACCESSORIES

Received Nov 19, 2025 · Event occurred Aug 18, 2025

Report 23595602 · MDR key 23595602

Device

Generic name

Stimulator, Nerve, Peripheral, Electric

Manufacturer

Nihon Kohden Corporation

Model number

AF-201P

Catalog number

AF-201P

Product problems

Material Integrity Problem

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NIHON KOHDEN NMT POD USES PROPRIETARY CABLE SETS THAT ARE DISPOSABLE AND NOT REUSABLE WITH NO OTHER OPTION FOR THE OPERATOR. THIS PLACES A BURDEN ON THE OPERATOR FROM A FINICAL PERSPECTIVE AND FROM A POTENTIAL SUPPLY CHAIN DISRUPTION SHOULD THE DISPOSABLE PRODUCT BECOME UNAVAILABLE.