InstaClear LCS4K00UNOLRecalls & reported problems
Gyrus ACMI, LLC · SHEATH, LENS CLEANER ULTRA 0 DEGREES, UNI. LIGHT InstaClear for use with Olympus 4 x 175 mm ULTRA scopes (5/PK) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925041462), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K152531); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE INSTACLEAR SHEATH METAL TUBE/PIN HAS DETACHED FROM THE SHEATH (SLEEVE). IT WAS COMPLETE AT THE BEGINNING OF THE PROCEDURE, BUT WAS MISSING/DETACHED AT THE END OF THE PROCEDURE. THE ISSUE OCCURRED DURING A THERAPEUTIC FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20369068 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152531. One submission often covers many models, so check the product and lot details in each record.
- Z-1888-2024 · Apr 3, 2024 · Open, ClassifiedInstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remo
- Z-1368-2024 · Jan 16, 2024 · Open, ClassifiedInstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LC
Other Nasopharyngoscope (Flexible Or Rigid) devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)785 reports
- NA 242268Medos International Sàrl · Nasopharyngoscope (flexible or rigid)573 reports
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Olympus Medical Systems Corp. · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)3 recalls1 death408 reports
- VIVIDEO VNL9-CPHoya Corporation · Nasopharyngoscope (Flexible Or Rigid)389 reports
- PENTAX FNL-10RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
- SINGLE USE SUCTION VALVE MAJ-209Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)228 reports
- PENTAX FNL-7RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.