SpyGlass DS M0054665R0Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729874362), received between Jun 23, 2020 and Nov 20, 2024 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TWO SPYSCOPE DS II ACCESS & DELIVERY CATHETERS AND A SPY DS CONTROLLER WERE ATTEMPTED FOR USE DURING A CHOLANGIOSCOPY PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE FOR A TEST PERIOD, WHEN THE BOSTON CONSOLE WAS SWITCHED ON BEFORE THE SPYSCOPE WAS INSERTED. IT TURNED ON AS USUAL, BUT WHEN THE CHOLANGIOSCOPE WAS PLUGGED IN, THERE WAS NO IMAGE OR LIGHT, SUGGESTING THAT THE DEVICE WAS NOT COMMUNICATING CORRECTLY WITH THE CONSOLE, EVEN AFTER REPLACING THE CHOLANGIOSCOPE WITH AN IDENTICAL UNIT FROM THE SAME BATCH. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AS A RESULT OF THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734491 ↗
• MalfunctionOct 30, 2024Connection Problem; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPY DS CONTROLLER WAS USED ON (B)(6) 2024. IT WAS REPORTED THAT WHEN CATHETER WAS CONNECTED TO UNIT, THE CONNECTION LIGHT CAME ON BUT AUTOMATICALLY POWERED OFF, WHEN CATHETER WAS PUSHED HARD INTO THE UNIT, LIGHT CAME ON AGAIN BUT AS SOON AS THE PUSH WAS RELEASED LIGHT WENT OFF. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568430 ↗
• MalfunctionJul 20, 2023Poor Quality Image; Poor Quality Image

  NOTES: THIS REPORT PERTAINS TO TWO SPYSCOPE DS II COMPLAINTS AND SPY DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II COMPLAINTS AND SPY DS CONTROLLER WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2023. DURING PREPARATION, THE CUSTOMER TRIED TO INSERT TWO SPYSCOPE DS II OF DIFFERENT BATCH NUMBER, BUT THE CONTROLLER DID NOT RECOGNIZE ANY OF THE SPYSCOPE DS II. THEY TRIED TO TURN THE CONTROLLER ON AND OFF FOR SEVERAL TIMES AND ALSO DISCONNECTING AND RECONNECTING THE POWER SUPPLY, HOWEVER; THE PROBLEM WAS NOT RESOLVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND RESCHEDULE ON (B)(6) 2023. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17362682 ↗
• MalfunctionFeb 27, 2023Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem

  NOTE: THIS REPORT PERTAINS TO TWO SPYSCOPE DS II ACCESS & DELIVERY CATHETERS AND SPYGLASS DS - DIGITAL CONTROLLER THAT WERE USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND SPYGLASS DS - DIGITAL CONTROLLER, WERE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SPY IMAGE STARTED GETTING CHOPPY APPROXIMATELY TWO MINUTES INTO THE PROCEDURE. THEN FIVE GREY DOTS APPEARED ON THE SCREEN. THEY RESET SPY AND SWAPPED OUT THE S-VIDEO CABLE; HOWEVER, NOTHING WAS CHANGED. THEY OPENED A SECOND SPYSCOPE DS II AND THE SAME THING HAPPENED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448726 ↗
• MalfunctionNov 22, 2022Poor Quality Image; Poor Quality Image

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THERE WAS NO IMAGE COMING FROM THE SPY DS CONTROLLER, ONLY THE COMPANY LOGO APPEARED AND DISAPPEARED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848157 ↗
• MalfunctionNov 10, 2022Connection Problem; Optical Problem; Connection Problem; Optical Problem

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND A SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II AND A SPYGLASS DS CONTROLLER WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE PORT OF THE CONTROLLER WAS NOT FUNCTIONAL WHEN THE CONNECTION CABLE FROM THE SPYSCOPE WAS PLUG. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774619 ↗
• MalfunctionNov 4, 2022Poor Quality Image; Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II AND SPY DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II AND SPYGLASS DS CONTROLLER WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SPYSCOPE DS II WAS NOT IMAGING CORRECTLY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15737373 ↗
• MalfunctionJun 23, 2022Poor Quality Image; Poor Quality Image

  NOTE: THIS REPORT PERTAINS TO A SPY DS CONTROLLER AND A SPYSCOPE DS II USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER AND A SPYSCOPE DS II WERE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE CONTROLLER WAS NOT ABLE TO RECOGNIZED THE SCOPES. THEY USED SEVERAL DIFFERENT SCOPES AND STILL THE PROBLEM PERSIST. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14791997 ↗
• MalfunctionMar 18, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. THE SPY DS CONTROLLER WAS POWERING OFF AUTOMATICALLY AFTER 6 SECONDS. THE CONTROLLER WAS REBOOTED FOR SEVERAL TIMES AND THE PROBLEM PERSISTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13810208 ↗
• MalfunctionDec 3, 2021Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO THE SPYSCOPE DS AND SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS AND A SPYGLASS DS CONTROLLER WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON NOVEMBER 17, 2021. DURING PREPARATION, THEY SAW AN INTERFERENCE IN THE IMAGE AFTER 3 MINUTES OF USING THE SPYGLASS. THEY CONNECTED AGAIN THE SPYSCOPE BUT HALF OF THE IMAGE IN THE SCREEN WAS OK AND THE OTHER HALF HAD LINES AND COLORS, SO THEY COULDN'T SEE THE VIDEO PROPERLY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924414 ↗
• MalfunctionNov 9, 2021Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO A SPYSCOPE DS II CATHETER AND A SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SPYSCOPE DS II CATHETER AND A SPYGLASS DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH CHOLANGIOSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. PRIOR TO THE PROCEDURE, NO IMAGE APPEARS ON THE SCREEN UPON PLUGGING THE SPYSCOPE DS II CATHETER INTO THE CONTROLLER AND THE LIGHT ON THE FRONT PANEL BUTTON OF THE CONTROLLER WILL NOT ILLUMINATE. THE CONTROLLER WAS REBOOTED AND PLUGGED THE SPYSCOPE DS II CATHETER; HOWEVER, THE PROBLEM WAS NOT RESOLVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782933 ↗
• MalfunctionOct 21, 2021Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO TWO SPYSCOPE DS II CATHETER AND A SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPYSCOPE DS II CATHETER AND A SPYGLASS DS CONTROLLER WERE USED DURING A CHOLANGIOSCOPE PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2021. DURING THE PROCEDURE, THE IMAGE OF THE SPYSCOPE DS II CATHETER WAS LOST APPROXIMATELY 20 SECONDS INTO THE PROCEDURE. A SECOND SPYSCOPE DS II CATHETER WAS USED AND SAME PROBLEM OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12674485 ↗
• MalfunctionSep 23, 2021Poor Quality Image; Optical Problem; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO THREE SPYSCOPE DS II CATHETER AND A SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE SPYSCOPE DS II CATHETER AND A SPYGLASS DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THERE WERE THREE SPYSCOPE DS II CATHETER FAILED TO CONNECT INTO THE CONTROLLER. THERE WAS NO LIGHT EVER CAME ON THE SPYSCOPE DS II CATHETER. THE LIGHT INTENSITY INDICATOR AND THE LIGHTBULB POWER BUTTON FLICKERED CONSISTENTLY. A LOADING DOTS COMING ON AND OFF ON THE SCREEN. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518802 ↗
• MalfunctionMay 13, 2021Poor Quality Image; Optical Problem; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Optical Problem; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT PERTAINS TO THE SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND SPYGLASS DS CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS II ACCESS & DELIVERY CATHETER AND SPYGLASS DS CONTROLLER WERE USED DURING A CHOLANGIOSCOPY PROCEDURE PERFORMED IN THE COMMON BILIARY DUCT ON (B)(6) 2021. DURING THE PROCEDURE, WHEN CONNECTING THE SPYSCOPE DS II INTO THE CONTROLLER, NO IMAGE APPEARED ON THE SCREEN. NO LIGHT SOURCE AT THE END OF THE CATHETER, SINGLE INTERMITTENT FLASHING THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822503 ↗
• MalfunctionDec 8, 2020Poor Quality Image; Appropriate Device Problem Term/Code Not Available; Poor Quality Image; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DS CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMAGE DISPLAYED A GRAY BOX EVEN THOUGH THE CONTROLLER POWER WAS ON. THE SPYSCOPE WAS CONNECTED AND NO IMAGE WAS DISPLAYED. REPORTEDLY, THE SPYSCOPE DS WAS SWITCHED OUT FOR ANOTHER SPYSCOPE DS; HOWEVER, THE IMAGE PROBLEM WAS NOT RESOLVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10968079 ↗
• MalfunctionAug 31, 2020Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown; Appropriate Device Problem Term/Code Not Available; Unexpected Shutdown

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DS CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH ELECTROHYDRAULIC LITHOTRIPSY (EHL) PROCEDURE PERFORMED IN THE BILIARY ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SPYGLASS DS CONTROLLER POWER SHUT DOWN DURING THE PROCEDURE. REPORTEDLY, THE POWER SOURCE WAS FLICKERING IN AND OUT AND THE FAN WAS MAKING A LOUD NOISE. THEY WERE UNABLE TO GAIN THE POWER BACK, AND AS A RESULT THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10474650 ↗
• MalfunctionAug 10, 2020Failure to Power Up; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DS CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THERE WAS NO LIGHT SOURCE COMING FROM THE SPYGLASS DS CONTROLLER. THE CONTROLLER WOULD COME ON FOR A SECOND THEN GO DORMANT. REPORTEDLY, THE CONTROLLER WAS REBOOTED; HOWEVER, THERE WAS STILL NO LIGHT SOURCE COMING FROM THE CONTROLLER. ALL CONNECTIONS WERE CHECKED INCLUDING THE OUTLETS WHICH WORKED WITH OTHER DEVICES. THE PROCEDURE WAS RESCHEDULED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10387155 ↗
• MalfunctionJul 22, 2020Optical Problem; Appropriate Device Problem Term/Code Not Available; Optical Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE DS AND A SPYGLASS DS CONTROLLER WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE CONTROLLER POWERS ON, THE FRONT PANEL BUTTON IS ILLUMINATED BUT NO LIGHT CONNECTS TO THE LIGHTS ON THE SPYSCOPE DS. A SECOND SPYSOPE DS WAS USED; HOWEVER, THERE WAS STILL NO LIGHTS COMING OUT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION 27JUL2020: REPORTEDLY, THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10308448 ↗
• MalfunctionJun 23, 2020Failure to Power Up; Appropriate Device Problem Term/Code Not Available; Failure to Power Up; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DS CONTROLLER WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE LIGHT SOURCE OF THE SPYGLASS DS CONTROLLER WAS NOT WORKING. REPORTEDLY, THE LIGHT BRIGHTNESS CONTROL BUTTONS WERE PRESSED AND POWER CORD CABLES WERE CONNECTED TIGHTLY; HOWEVER, THEY WERE NOT ABLE TO ADJUST THE BRIGHTNESS OF THE CONTROL BUTTONS. THE ERCP WAS COMPLETED; HOWEVER, THE CHOLANGIOSCOPY PORTION OF THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND NEEDED TO BE RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184700 ↗