Single use Surgical Optical FiberRecalls & reported problems across all models
Quanta System SPA · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 18 models of Single use Surgical Optical Fiber by Quanta System SPA in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2019 and Apr 29, 2026 — classified as 2 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Single use Surgical Optical Fiber problems
Device problems
- Therapeutic or Diagnostic Output Failure24
- Appropriate Device Problem Term/Code Not Available15
- Fracture7
- Break6
- Output Problem6
- Detachment of Device or Device Component4
- Defective Component3
- Defective Device3
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Known Impact Or Consequence To Patient32
- Hemorrhage/Blood Loss/Bleeding3
- No Consequences Or Impact To Patient2
- Blister1
- Foreign Body In Patient1
Single use Surgical Optical Fiber models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Single use Surgical Optical Fiber EMP-FBX272HSPowered Laser Surgical Instrument15 reports
- Single use Surgical Optical Fiber EMP-FBX200HSPowered Laser Surgical Instrument10 reports
- Single use Surgical Optical Fiber EMP-FBX200BHSPowered Laser Surgical Instrument7 reports
- Single use Surgical Optical Fiber EMP-FBX272HS-CPowered Laser Surgical Instrument7 reports
- Single use Surgical Optical Fiber OAF005511Powered Laser Surgical Instrument3 reports
- Single use Surgical Optical Fiber OAF702711Powered Laser Surgical Instrument3 reports
- Single use Surgical Optical Fiber OFH302721Powered Laser Surgical Instrument3 reports
- Single use Surgical Optical Fiber EMP-FBX365HSPowered Laser Surgical Instrument3 reports
- Single use Surgical Optical Fiber EMP-FBX200BHS-CPowered Laser Surgical Instrument3 reports
- Single use Surgical Optical Fiber OAF002011Powered Laser Surgical Instrument2 reports
- Single use Surgical Optical Fiber OFH302711Powered Laser Surgical Instrument2 reports
- Single use Surgical Optical Fiber OAF009911Powered Laser Surgical Instrument1 report
- Single use Surgical Optical Fiber OAF002701Powered Laser Surgical Instrument1 report
- Single use Surgical Optical Fiber OAF009901Powered Laser Surgical Instrument1 report
- Single use Surgical Optical Fiber OAF703611Powered Laser Surgical Instrument1 report
- Single use Surgical Optical Fiber OFH002711Powered Laser Surgical Instrument1 report
- Single use Surgical Optical Fiber EMP-FBX550HSPowered Laser Surgical Instrument1 report
- Single use Surgical Optical Fiber EMP-FBX1000HSPowered Laser Surgical Instrument1 report
Recent Single use Surgical Optical Fiber adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2026Overheating of Device
A FLAME WAS OBSERVED ON THE LASER FIBER NEAR THE CONNECTION TO THE LASER MACHINE. THE FLAME WAS IMMEDIATELY CALLED OUT AND EXTINGUISHED WITH A WET TOWEL. NO HARM OR INJURY TO PATIENT WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031045 ↗MalfunctionApr 29, 2026Insufficient Device Problem Information
ON (B)(6) 2026, DURING A HOLEP (HOLMIUM LASER ENUCLEATION OF THE PROSTATE) PROCEDURE, MULTIPLE DEVICE MALFUNCTIONS WERE OBSERVED INVOLVING THE LASER BLAST SHIELD AND LASER FIBERS. APPROXIMATELY 30 MINUTES INTO THE PROCEDURE, THE BLAST SHIELD BURNED DURING LASER ACTIVATION. THE AFFECTED LASER FIBER (A253220) AND BLAST SHIELD WERE REPLACED. FOLLOWING REPLACEMENT, A SECOND BLAST SHIELD BURNED WITHIN APPROXIMATELY 5 MINUTES OF USE WHILE USING A NEW LASER FIBER (A252725). AS A RESULT, THE PRIMARY LASER SYSTEM WAS REPLACED WITH A LOAN UNIT (SERIAL NUMBER (B)(6). A NEW LASER FIBER (A252726) AND BLAST SHIELD WERE INSTALLED; HOWEVER, THE SAME ISSUE REOCCURRED, WITH THE BLAST SHIELD AGAIN BURNING DURING USE. DUE TO ONGOING BLEEDING AND THE FACT THAT THE PATIENT WAS A (B)(6) WITNESS (BLOOD PRODUCTS CONTRAINDICATED), A SECOND CLINICIAN WAS REQUIRED TO ATTEND IN ORDER TO COMPLETE THE PROCEDURE. THIS RESULTED IN AN APPROXIMATELY 20 MINUTE DELAY WHILE THE SECOND CLINICIAN ATTENDED THE OPERATING LIST. THE PROCEDURE WAS EVENTUALLY COMPLETED BY RESTARTING THE LOAN LASER UNIT (B)(6) WITH A NEW BLAST SHIELD AND A NEW LASER FIBER, AFTER WHICH THE DEVICE FUNCTIONED SUFFICIENTLY TO FINISH THE SURGERY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 25027129 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER STATED BELIEVE THE LASER CAUSED EXCESSIVE BLEEDING DURING 2 HOLEPS, WHICH LEAD TO 2 PATIENTS BEING RE-ADMITTED LAST NIGHT FOR BLOOD CLOTS. HE DID REQUEST THAT WE INVESTIGATE FIBER LOT A253165. THIS IS THE SAME LOT THAT WAS USED WHEN MULTIPLE BLAST SHIELDS BLEW.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24681602 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORTER, THE CUSTOMER STATED BELIEVE THE LASER CAUSED EXCESSIVE BLEEDING DURING 2 HOLEPS, WHICH LEAD TO 2 PATIENTS BEING RE-ADMITTED LAST NIGHT FOR BLOOD CLOTS. HE DID REQUEST THAT WE INVESTIGATE FIBER LOT A253165. THIS IS THE SAME LOT THAT WAS USED WHEN MULTIPLE BLAST SHIELDS BLEW.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24681594 ↗MalfunctionApr 21, 2025Fracture; Material Separation
DURING CYSTOSCOPY/URETEROSCOPY AND HOLMIUM LASE, OPTIC FIBER FRACTURED WHILE INSIDE PATIENT. PATIENT HAD MULTIPLE LARGE STONES. ALL PIECES OF THE FIBER WERE REMOVED FROM THE PATIENT, NO INJURY NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874420 ↗MalfunctionFeb 13, 2025Break; Output Problem; Break; Output Problem
DURING SURGERY, THE DEVICE BROKE OFF INSIDE THE PATIENT. THE INITIAL CLINICAL PROCEDURE (LITHOTRIPSY) WAS COMPLETED TO THE BEST OF THE DOCTOR'S ABILITY. UPON REALIZING THE FIBER HAD BROKEN, THE DOCTOR ATTEMPTED TO RETRIEVE IT BUT WAS UNSUCCESSFUL, DECIDING TO LEAVE THE ITEM IN PLACE. THE PATIENT RETURNED FOUR WEEKS LATER FOR SURGERY TO REMOVE THE FRAGMENT. THERE WERE NO FURTHER CLINICAL REPERCUSSIONS FOR THE PATIENTS.
Patient problems: Foreign Body In Patient
MAUDE report 21372676 ↗MalfunctionFeb 22, 2023Protective Measures Problem
MALFUNCTIONED WHILE TESTING-- DID NOT REACH PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16416472 ↗MalfunctionApr 21, 2022Fracture; Fracture
OPTICAL FIBER BROKE CAUSING A BLISTER TO THE OPERATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14166134 ↗MalfunctionFeb 11, 2022Break; Break
THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13512204 ↗MalfunctionNov 18, 2021Break; Fracture; Break; Fracture
OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW ITS USE ANYMORE. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12834265 ↗MalfunctionNov 4, 2021Fracture; Fracture
BROKEN OPTICAL FIBER. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12750381 ↗MalfunctionJun 4, 2021Fracture; Fracture
THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11942527 ↗MalfunctionMay 11, 2021Break; Fracture; Fracture
FIBER TIP BROKE INSIDE THE PATIENT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11805686 ↗MalfunctionApr 20, 2021Mechanical Problem; Mechanical Problem
FIBER BOKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11691800 ↗MalfunctionApr 3, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE OPTICAL FIBER HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11611800 ↗
Other Quanta System SPA products
All Quanta System SPA devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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