inforMED
MalfunctionFAS

Electrode, unipolar, pointed

Received Jul 27, 2026

Report 9610617-2026-01701 · MDR key 50000125

Device

Generic name

Electrode, Unipolar, Pointed

Model number

011111-10

Catalog number

011111-10

Lot number

844037

Product problems

  • Break

Patient

Not reported

  • Insufficient Information

Narrative

Description of Event or Problem

It was reported that the surgeon was using two Collins knives in one procedure. During the procedure, both knives fractured and split into two pieces while in use. No negative impact in state of health reported.Cross reference MDR:9610617-2026-01702.

Additional Manufacturer Narrative

The device in question will not be returned to manufacturer for evaluation, product was discarded after procedure by user. The investigation is not yet complete, investigation results are pending.The event is filed under internal KARL STORZ complaint ID: (b)(4).Cross reference internal complaint ID:(b)(4).