NA 242386Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886705028818), received between Jan 9, 2020 and Sep 14, 2026 — classified as 49 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (26 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

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762645 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT BEFORE SHOULDER ARTHROSCOPY SURGERY, THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE WAS UNABLE TO CONNECT TO THE LENS PROPERLY DUE TO A LIGHT GUIDE BUNDLE. UPON INSPECTION, IT WAS FOUND THAT THE SPRING RING WAS DETACHED AT THE INTERFACE OF THE DEVICE. REPLACE THE LIGHT GUIDE AND SOLVE THE PROBLEM AFTER SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958032 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A FUSLITEGU_OLYM-ACMI_3.5MMX3.0M LIGHT CORD BEFORE A SHOULDER ARTHROSCOPY. THE CONNECTOR TAB THAT CONNECTS THE CORD TO THE SCOPE FELL OFF. THE PATIENT WAS NOT AFFECTED AND THE EVENT HAPPENED BEFORE THE CASE STARTED. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441547 ↗
• MalfunctionFeb 5, 2026Break; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY PROCEDURE, THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE LIGHT TRANSMITTING BUNDLE COULD NOT CONDUCT LIGHT NORMALLY AND THE INTERFACE WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268624 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO SCOPES FROM THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICES FELL OFF DUE TO THE MAGNET NOT HOLDING THEM PROPERLY IN PLACE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727237 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, TWO SCOPES FROM THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICES FELL OFF DUE TO THE MAGNET NOT HOLDING THEM PROPERLY IN PLACE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727228 ↗
• MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FUSLITEGU_OLYM-ACMI DEVICE CONNECTION TO THE SCOPE WOULD BECOME EASILY DETACHED. THEREFORE, THE SILVER CONNECTION PART REMAINS IN THE SCOPE SIDE WITHOUT FAIL WHEN YOU DETACH THE DEVICE FROM THE SCOPE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22233355 ↗
• MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM THAT THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE, AFTER THE SURGERY, THE CONNECTION TO THE SCOPE HAD BECOME EASILY DETACHED. THEREFORE, THE SILVER CONNECTION PART REMAINS IN THE SCOPE SIDE WITHOUT FAIL WHEN YOU DETACH THE DEVICE FROM THE SCOPE. THIS EVENT OCCURS EVERY TIME THE DEVICE IS USED, CAUSING PROBLEMS FOR THE SURGEON. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THE EXACT DATE OF THIS EVENT WAS UNKNOWN BUT WAS NOTED TO HAVE OCCURRED IN 2025. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201380 ↗
• MalfunctionMay 28, 2025Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping; Device-Device Incompatibility; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE FUSLITEGU OLYM-ACMI_3.5MMX3.0M DEVICE END THAT CONNECTS TO THE SCOPE DID NOT SECURE TO THE SCOPE AND WAS CONSISTENTLY FALLING OFF AND NOT LOCKING INTO PLACE. ACCORDING TO THE REPORTER, THE SLIGHTEST MOVEMENT WOULD DETACH THE LIGHT CORD FROM THE SCOPE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT FOREIGN DEBRIS/MATTER WAS FOUND INSIDE OF THE CONNECTOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094902 ↗
• MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE (ARCR) FOR A ROTATOR CUFF TEAR ON THE SHOULDER JOINT, WHILE USING THE CORDCUTTER DEVICE SCOPE THE USER TRIED TO REMOVE THE SCOPE SIDE OF THE LIGHT GUIDE CABLE THAT SUPPLIES THE LIGHT SOURCE TO THE CAMERA SYSTEM, THE ADAPTER CAME OFF ALONG WITH IT. THIS ADAPTER PART IS NOT SUPPOSED TO COME OFF, BUT IT DID. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090088 ↗
• MalfunctionMar 11, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ADAPTOR PIECE ON THE END OF THE FUSLITEGU_OLYM-ACM 3.5MM X 3.0M LIGHT GUIDE CHORD FELL OFF AND WAS UNABLE TO INSERT INTO THE CSS BOX. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577498 ↗
• MalfunctionFeb 26, 2025Break; Break

  IT WAS REPORTED THAT DURING SETUP, IT WAS OBSERVED THAT THE FUSLITEGU OLYM-ACMI 3.5MMX3.0M DEVICE HAD SUSTAINED PHYSICAL DAMAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES): DEVICE FRACTURED. THE EVENT DID NOT OCCUR DURING TO SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470224 ↗
• MalfunctionFeb 21, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE END CAP ON THE DEVICE WAS MISSING. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CONNECTOR ON THE FEMALE END WAS FOUND DETACHED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433445 ↗
• MalfunctionFeb 12, 2025Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR (ARCR) SURGICAL PROCEDURE ON THE SHOULDER JOINT FOR A SHOULDER ROTATOR CUFF TEAR THE FUSLITEGU_OLYM DEVICE ADAPTER ON THE SCOPE SIDE OF THE LIGHT CABLE WAS ORIGINALLY DESIGNED NOT TO COME OFF; HOWEVER, IT COULD BE REMOVED. THE NURSE NOTICED IT RIGHT AFTER THE SURGERY STARTED. THE ADAPTER WAS AGAIN EASY TO ATTACH AND THE LIGHT CABLE COULD BE ATTACHED TO THE SCOPE WITHOUT ANY PROBLEMS. AFTER SURGERY, IT WAS CONFIRMED THAT THE ADAPTER COULD BE REMOVED AGAIN. THERE WAS NO DELAY TO THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368797 ↗
• MalfunctionFeb 12, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IT WAS OBSERVED THAT THE FIBEROPTIC LIGHT DEVICE CORD WAS MISSING THE MAGNET ADAPTER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE OPTICAL DEVICE CONNECTOR ON THE FEMALE SIDE WAS DETACHED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362619 ↗
• MalfunctionFeb 10, 2025Break; Display or Visual Feedback Problem; Use of Device Problem; Break; Display or Visual Feedback Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-SURGERY FOR AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE LIGHT GUIDE OLYM-ACMI_3.5MMX3.0M DEVICE HAD BAD LIGHT CORD, WAS VERY DULL AND COULD NOT GET IMAGE QUALITY TO WORK. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21342415 ↗
• MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED FROM JAPAN THAT DURING A MENISCUS REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SCREW ON THE SCOPE SIDE OF THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M LIGHT GUIDE CAME OFF DURING CLEANING. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909435 ↗
• MalfunctionOct 2, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING PRE-SURGERY FOR AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS DISCOVERED THAT THE LIGHT GUIDE, OLYMPUS - ACMI 5.0MM X 4.0M DEVICE FIBRES WERE BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350521 ↗
• MalfunctionOct 1, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT AT THE START OF A SCOPE PROCEDURE, IT WAS DISCOVERED THAT THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE WAS MISSING AN ATTACHMENT FOR THE SCOPE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN (2+ PIECES) : DEVICE FRACTURED. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345810 ↗
• MalfunctionSep 16, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE LIGHT GUIDE, OLYMPUS - ACMI 3.5MM X 3.0 DEVICE HAD A MISSING ATTACHMENT FOR THE SCOPE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE FEMALE CONNECTOR WAS MISSING ON THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224898 ↗
• MalfunctionSep 4, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ARTHROSCOPY PROCEDURE, IT WAS DISCOVERED THAT THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE HAD A SUPERFICIAL RUPTURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136445 ↗
• MalfunctionAug 23, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE LIGHT GUIDE OLYM-ACMI_3.5MMX3.0M WAS MISSING KEYS ON THE BOTTOM END. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE FEMALE CONNECTOR WAS MISSING ON THE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056448 ↗
• MalfunctionAug 5, 2024Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THIS WAS AN UNKNOWN SURGERY PERFORMED ON UNKNOWN DATE. WHEN THE LIGHT CABLE. IT WAS REPORTED FROM JAPAN THAT POSTOPERATIVELY TO AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT WHEN THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE WAS TAKEN OFF FROM THE CAMERA UNIT, THE CONNECTION THAT SHOULD NOT HAVE BEEN REMOVED HAVE COME OFF. THE SURGEON SUSPECTED THAT THE ADHESIVE MELTED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19905836 ↗
• MalfunctionJul 2, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT POSTOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE OF THE ANKLE, IT WAS OBSERVED THAT AN UNKNOWN PART ON THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE THAT WAS NOT SUPPOSED TO COME OFF, CAME OFF. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CONNECTOR ON THE DEVICE WAS DETACHED. THIS DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659364 ↗
• MalfunctionJun 2, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SPINAL PROCEDURE THE FUSLITEGU_OLYM-ACMI_3.5MMX3.0M DEVICE HAD A LIGHT TRANSMITTANCE ISSUE. IT WAS REPORTED THAT DURING THE OPERATION, NOTED THE LIGHT TRANSMISSION OF THE FIBER WAS POOR. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444759 ↗