NA 72202962Recalls & reported problems
Smith & Nephew, Inc. · VIDEOARTHROSCOPE NON-AUTOCLAVABLE, BLACK FOCUS RING, 19.5 MM FOCAL LENGTH, 4.0 MM OUTER DIAMETER X 70 DEGREE DIRECTION OF VIEW, 115 DEGREE FIELD OF VIEW, · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885554024166), received between Dec 11, 2018 and Jul 16, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Crack” (3 reports).
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.
Most reported problems
Device problems
- Crack3
- Material Integrity Problem3
- Optical Obstruction3
- Break2
- Misfocusing1
- Moisture or Humidity Problem1
- Poor Quality Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2023Misfocusing; Material Integrity Problem; Moisture or Humidity Problem; Misfocusing; Material Integrity Problem; Moisture or Humidity Problem
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, THE VIDEO ARTHROSCOPE DID NOT FOCUS. THERE WAS A BACK-UP DEVICE AVAILABLE AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17330930 ↗MalfunctionOct 21, 2022Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT DURING USE, THE VIDEO ARTHROSCOPE WAS UNVIEWABLE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15655902 ↗MalfunctionOct 21, 2022Break; Crack; Material Integrity Problem; Optical Obstruction; Break; Crack; Material Integrity Problem; Optical Obstruction
IT WAS REPORTED THAT DURING USE, THE VIDEO ARTHROSCOPE WAS UNVIEWABLE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15655462 ↗MalfunctionOct 21, 2022Break; Crack; Material Integrity Problem; Optical Obstruction; Break; Crack; Material Integrity Problem; Optical Obstruction
IT WAS REPORTED THAT DURING USE, THE VIDEO ARTHROSCOPE WAS UNVIEWABLE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WAS A SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15655407 ↗MalfunctionJan 21, 2021Crack; Crack
IT WAS REPORTED THAT DURING A HIP CASE THE EXTERNAL LENS OF THE SCOPE WAS CRACKED. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11208025 ↗MalfunctionDec 11, 2018Poor Quality Image
IT WAS REPORTED A BAD IMAGE. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. BACK UP DEVICE WAS NOT AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8150411 ↗
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.