NA 72202961Recalls & reported problems
Smith & Nephew, Inc. · BLACK FOCUS RING, 19.5 MM FOCAL LENGTH, 4.0 MM OUTER DIAMETER, 30 DEGREE DIRECTION OF VIEW, 115 DEGREE FIELD OF VIEW, 160 MM WORKING LENGTH, OPPOSITE, J-LOCK, NON-AUTOCLAVABLE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885554024159), received between Mar 29, 2019 and Oct 9, 2023 — classified as 6 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Optical Obstruction” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Optical Obstruction5
- Poor Quality Image3
- Crack2
- No Display/Image2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Insufficient Device Problem Information1
- Moisture Damage1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
- No Code Available1
- No Information1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2023Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE SCOPE HAD UNCLEAR IMAGE AND ON THE ONE CORNER OF THE IMAGE THERE WAS SOME SCRATCHES NOTICED AND A DARK SHADOW. THE SURGEON COULD NOT VIEW THE ENTIRE IMAGE. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE (OPEN TECHNIQUE). THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17901646 ↗MalfunctionNov 15, 2022Optical Distortion; Optical Obstruction; Optical Distortion; Optical Obstruction
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE VIDEOARTHROSCOPE HD LENS WAS VERY BLURRY AND A RING WAS VISIBLE ON THE SIDE OF THE IMAGE. SURGERY WAS COMPLETED AFTER A DELAY GREATER THAN 30 MINUTES, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15796310 ↗MalfunctionNov 7, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SET UP OR INSPECTION, AN UNKNOWN DEVICE WAS HEATING UP. THERE WAS A S+N BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15746739 ↗MalfunctionJun 2, 2021Crack; Crack
IT WAS REPORTED THAT DURING KNEE ARTHROSCOPY PROCEDURE, THE VIDEOARTHROSCOPE HAD AN UNSPECIFIED FAILURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. PRELIMINARY RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD RACKED DISTAL LENS WHICH MAKES IT A REPORTABLE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11920486 ↗MalfunctionFeb 25, 2021Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE VIDEOARTHROSCOPE IMAGE WAS NOT CLEAR. THE PROCEDURE WAS SUCCESSFULLY USING A BACK UP DEVICE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED. 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 11378489 ↗InjuryFeb 23, 2021Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT THE VIDEOARTHROSCOPE DID NOT WORK AS USUAL, IT HAD VERY SMOKY IMAGE FROM THE BEGINNING OF ACL RECONSTRUCTION SURGERY. THERE WAS A DELAY AROUND 15 MINUTES, TO PREPARE AND CHANGE THE SET UP FOR OPENING THE KNEE IN ORDER TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. 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 11367832 ↗InjuryJan 3, 2021Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING MENISCUS REPAIR SURGERY, THE SCOPE GOT SPOILT, THERE WERE DROPS OF WATER VISIBLE ON THE SCREEN. THE SCOPE GAVE A VERY POOR IMAGE, AT TIMES IMAGE NOT EVEN VISIBLE. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE AND THERE WAS A DELAY GREATER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED. 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 11105990 ↗InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, WHILE USING A VIDEOARTHROSCOPIC AND A AMBIENT SUPER TURBOVAC TO REMOVE SOFT TISSUE FOR A DECOMPRESSION, THE SCOPE'S TIP MIGHT HAVE CRACKED. THE MALFUNCTION WAS SOLVED WITH NO DELAYS OR PATIENT HARM USING A BACK UP DEVICE. 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 11036471 ↗MalfunctionNov 26, 2020Break; Break
IT WAS REPORTED THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR, THE VIDEO ARTHROSCOPE WAS SPOILT, IT WAS SEPARATED INTO TWO PARTS AND WAS NOT ABLE TO SCREW BACK. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE AND NO OTHER COMPLICATIONS WERE REPORTED. 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 10912540 ↗InjuryNov 19, 2020Optical Obstruction; Optical Obstruction
IT WAS REPORTED THAT UPON CHECKING THE CAMERA SYSTEM BEFORE AN ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT THE PICTURE WAS NOT CLEAR, IT WAS BLACK WHEN LOOKING THROUGH THE VIDEOARTHROSCOPE WHICH APPEARS DAMAGED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE WITH A DELAY SHORTER THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10865845 ↗InjuryAug 22, 2020Crack; Crack
IT WAS REPORTED THAT DURING A SUBACROMIAL DECOMPRESSION, THE TIP OF THE SCOPE WAS CRACKED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Information
MAUDE report 10440442 ↗MalfunctionNov 18, 2019Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT UPON SWITCHING ON THE CAMERA SYSTEM NO CLEAR PICTURE COULD BE SEEN ON THE SCREEN, ONLY A BLURRY, DULL PICTURE. AFTER INSPECTING THE LENS THE SHAFT APPEARED BENT. THIS OCCURRED AT THE START OF A KNEE ARTHROSCOPY PROCEDURE. THE SURGERY WAS POSTPONED TO ANOTHER DATE AS THERE WAS NO BACK UP AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9337017 ↗MalfunctionOct 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING A SHOULDER SURGERY, THE DEVICE LENS WAS CRACKED. THE PROCEDURE WAS COMPLETE WITHOUT SIGNIFICANT DELAY WITH A COMPETITOR BACK UP DEVICE (STRYKER). NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9155987 ↗MalfunctionJul 22, 2019No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SHAFT OF THE CAMERA LENS HAS BEEN BENT, AND THERE IS NO PICTURE SEEN THROUGH THE LENS AT ALL ANYMORE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8813303 ↗MalfunctionJul 22, 2019No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SHAFT OF THE CAMERA LENS HAS BEEN BENT, AND THERE IS NO PICTURE SEEN THROUGH THE LENS AT ALL ANYMORE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8813243 ↗MalfunctionMar 29, 2019Moisture Damage; Poor Quality Image
IT WAS REPORTED THAT DURING CASE, WHEN DOING A DEMO OF LENS SYSTEM AT (B)(6) HEALTHCARE, THE FIRST TELESCOPE THEY USE HAD A GRAINY PICTURE AND SEEMED TO HAD WATER BETWEEN THE CAMERA HEAD AND THE SCOPE. THEY CHANGE THE SCOPE DURING THE SECOND CASE AND THE QUALITY OF THE PICTURE WAS PERFECT. NO PATIENT INJURIES REPORTED, NO DELAYS AND BACK-UP DEVICE WAS AVAILABLE. DURING THE PROCEDURE THERE WAS LOSS OF IMAGE, AND A BACK-UP WAS USED TO FINISH THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8466706 ↗
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- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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