Saeed G31917Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00827002319172), received between Feb 19, 2016 and Sep 21, 2026 — classified as 8 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (30 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 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843193 ↗
• MalfunctionAug 16, 2026Device Handling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268238 ↗
• MalfunctionAug 16, 2026Device Handling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268236 ↗
• MalfunctionAug 16, 2026Device Handling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50268232 ↗
• MalfunctionAug 13, 2026Device Dislodged or Dislocated; Material Too Soft/Flexible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232987 ↗
• InjuryJul 1, 2026Device Dislodged or Dislocated

  DURING A LIGATION PROCEDURE FOR GASTRIC / ESOPHAGEAL BLEEDING, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE PATIENT REQUIRED A GASTROSCOPY TO RULE OUT AN UPPER GI BLEED DUE TO MELENA STOOLS. PATIENT WAS HEMODYNAMICALLY STABLE. CONSCIOUS SEDATION ADMINISTERED. LARGE ESOPHAGEAL VARICES WITH HIGH-RISK SPOTS VISUALIZED. ONE OF WHICH APPEARED THAT IT HAD BEEN BLEEDING (RED WHEAL SPOT). THERE WAS AN ATTEMPT TO DEPLOY A BAND TO THE VARIX, BUT IT FELL OFF. CONSEQUENTLY, VARIX RUPTURED AND THERE WAS PROFUSE BLEEDING. SCOPE WAS REMOVED, BANDING DEVICE REMOVED AND SCOPE INSERTED AGAIN TO ATTEMPT THROMBOJET INJECTION TO BLEEDING SITE, THIS WAS UNSUCCESSFUL AS IT WAS IMPOSSIBLE TO LOCATE THE BLEEDING SITE DUE TO SEVERE BLEEDING. 300ML OF FRESH BLOOD SUCTIONED FROM PATIENT'S MOUTH/NOSE. AIRWAYS WERE MAINTAINED. PATIENT BECAME HYPOXEMIC DESPITE OXYGEN 3L/MIN VIA NASAL CANNULA, AND CODE 66 WAS CALLED. WHILE WAITING FOR THE CODE TEAM, OXYGENATION AND AIRWAYS WERE MAINTAINED.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 25680534 ↗
• MalfunctionMar 30, 2026Device Handling Problem

  IN PREPARATION FOR AN ESOPHAGOGASTRODUODENOSCOPY WITH BANDING, THE PHYSICIAN SELECTED FOUR COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS REPORTED THAT PRIOR TO USE THE PHYSICIAN ALWAYS FIRES OFF ONE BAND, THE BANDS ARE NOT THE SIZE THEY SHOULD BE WHEN COMING OFF THE BARREL. THEY APPEAR TO BE BIGGER THAN NORMAL. IN THE PICTURE [PROVIDED FOR EVALUATION], THE SMALL BAND CAME FROM [THE DEVICE] THAT WAS USED TO COMPLETE THE PROCEDURE. ALL FOUR DEVICES WERE USED IN THE SAME PROCEDURE AND THE DEVICES WERE DISCARDED AFTER THE INITIAL BAND WAS FIRED OFF BEFORE MAKING PATIENT CONTACT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717882 ↗
• MalfunctionJan 26, 2026Failure to Fire

  DURING AN ESOPHAGODUODENOSCOPY WITH VARICEAL BANDING IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT ONE OF THE LIGATORS MALFUNCTIONED AND WOULD NOT FIRE THE BAND. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179305 ↗
• MalfunctionNov 18, 2025Detachment of Device or Device Component

  FAULTY THREADER BLUE HOOKS CAME OFF BOTH ENDS TRYING TO THREAD THE STRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23583996 ↗
• MalfunctionOct 16, 2025Failure to Fire; Failure to Fire

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE "BANDER STRING KEPT SLIPPING OFF." [INTERPRETED AS UNABLE TO EFFECTIVELY DEPLOY BANDS - SUBJECT OF REPORT]. THEY HAD TO ATTEMPT 4 TIMES TO GET IT TO STAY IN PLACE AND REALLY HAD TO CRANK ON THE DIAL TO GET THE BAND TO RELEASE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23313131 ↗
• MalfunctionSep 17, 2025Premature Activation; Premature Activation

  DURING PREPARATION FOR AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE "RUBBER BAND WASN'T UNDER CONTROL." TWO BANDS WAS [WERE] DROPPED OFF BY ITSELF [PREMATURE DEPLOYMENT] AFTER FIXED THE BARREL AND BEFORE INTRODUCED INTO PATIENT. AFTER INSERTED TO PATIENT, THE DEVICE WAS UNABLE TO FIRE THE BANDS. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072760 ↗
• MalfunctionAug 14, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A VARICEAL LIGATION (EVL) PROCEDURE FOR ESOPHAGEAL VARICES, THE PHYSICIAN CHOSE A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS WERE PLACE ON THE VARIX, THEN RELEASED AND WENT INSIDE THE BARREL. IT SEEMS LIKE THE BANDS SLIPPED OFF TISSUE RIGHT AWAY. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803279 ↗
• MalfunctionJun 11, 2025Device Handling Problem; Device Handling Problem

  IN PREPARATION FOR A GASTROSCOPY PROCEDURE FOR LIGATION OF ESOPHAGEAL VARICES, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE CLINICIAN DEPLOYED A BAND OUTSIDE OF THE PATIENT TO TEST THE BAND. THIS IS NORMAL PROCEDURE FOR THIS CLINICIAN. THE CLINICIAN OBSERVED THE BAND DID NOT RESTRICT IN SIZE AS IT USUALLY WOULD [SUBJECT OF REPORT]. THE CLINICIAN THEN USED THIS DEVICE ON A PATIENT'S VARICES, DEPLOYING 2 X BANDS. ANOTHER OF THE SAME DEVICE WAS SET UP ON ANOTHER GASTROSCOPE AND ALL 6 X BANDS WERE DEPLOYED TO TREAT ESOPHAGEAL VARICES. HEMOSTASIS WAS ACHIEVED AND THE PATIENT REQUIRED NO FURTHER TREATMENT. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183153 ↗
• MalfunctionMay 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN ESOPHAGEAL VARICES' LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS DIDN'T FUNCTION AND DID NOT HOLD ON TO THE VARIX. 4 BANDS DEPLOYED BUT NONE WERE ABLE TO LIGATE ANY VARIX. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080431 ↗
• MalfunctionApr 18, 2025Premature Activation; Premature Activation

  DURING AN UNSPECIFIED LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE FIRST TWO BANDS DEPLOYED CORRECTLY BUT THE LAST 4 MISFIRED. OTHER THAN THE DEPLOYED BANDS, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867252 ↗
• MalfunctionApr 4, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IN PREPARATION FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE USER SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT WHEN PASSING THE COOK 6 SHOOTER BANDING KIT THROUGH THE SCOPE, THE THREADING DEVICE BROKE (BLUE THREADER BROKE OFF WHEN PULLING IT THROUGH DEVICE IN SCOPE). THEY ATTEMPTED TO USE THE OTHER END OF THE BLUE THREADER, AND IT BROKE OFF WHEN PULLING THROUGH SCOPE ATTACHMENT WHEEL AS WELL. USED A SECOND KIT AND HAD NO FURTHER PROBLEMS WITH IT. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774612 ↗
• MalfunctionMar 21, 2025Break; Failure to Fire; Break; Failure to Fire

  DURING AN UNSPECIFIED LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT WHEN THE ENDOSCOPE WAS REMOVED, WE [USERS] NOTICED THAT THE "WIRES HOLDING THE CAP (ON WHICH THE LIGATURES ARE PLACED) WERE SEVERED" [TRIGGER CORD BROKEN]. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21668000 ↗
• MalfunctionMar 19, 2025Premature Activation; Premature Activation

  DURING AN UNSPECIFIED LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE LAST LIGATION WAS NEVER FOUND, NOR INITIATED, NOR SEEN [INTERPRETED AS BAND PREMATURELY DEPLOYS]. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646594 ↗
• MalfunctionMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN UNSPECIFIED LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT ONE LIGATURE WAS TRIGGERED BUT DID NOT STAY IN PLACE [BANDS FALLS OFF VARIX]. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21646592 ↗
• MalfunctionMar 5, 2025Failure to Fire; Failure to Fire

  DURING A LIGATION PROCEDURE FOR ESOPHAGEAL VARICES, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT THE BANDS WOULD NOT DEPLOY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526983 ↗
• MalfunctionJan 7, 2025Failure to Fire; Failure to Fire

  DURING AN UNSPECIFIED LIGATION PROCEDURE THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS DEFECTIVE AFTER ASSEMBLY ON THE INSTRUMENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION ABOUT THE EVENT WAS RECEIVED ON 11 DEC 2024 STATING THAT THE RELEASE SYSTEM LOCKED AFTER MOUNTING ON THE INSTRUMENT [INTERPRETED AS UNABLE TO ROTATE THE HANDLE LEADING TO UNABLE TO DEPLOY BANDS]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21093040 ↗
• MalfunctionNov 21, 2024Device Dislodged or Dislocated; Material Too Soft/Flexible; Device Dislodged or Dislocated; Material Too Soft/Flexible

  DURING A VARICEAL LIGATION PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED 2 COOK 6 SHOOTER SAEED MULTI-BAND LIGATORS. IT WAS REPORTED THAT THERE WAS A COMPLAINT BUT NO FURTHER DETAILS WERE PROVIDED. NO DETAILS WERE PROVIDED THAT HAS HISTORICALLY CAUSED OR CONTRIBUTED TO A SERIOUS INJURY TO THE PATIENT, THEREFORE THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 28 OCT 2024 STATING THAT THE FIRST RINGS WERE EASY TO SET AND THE OTHER RINGS COULD BE REMOVED, BUT DID NOT FIT OVER THE SUCKED-IN TISSUE. THE TISSUE WAS OPTIMALLY SUCKED IN AS THE PHYSICIAN HAS A LOT OF EXPERIENCE WITH OUR 6-SHOOTER. THE RINGS THEN LAY LOOSE IN THE PATIENT. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745915 ↗
• MalfunctionNov 21, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IN PREPARATION FOR A LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE EXTRACTION THE BLUE HOOK, WHERE THE TRIGGER CHORDS IS ATTACHED TO, BROKE [INTERPRETED AS BLUE HOOK DETACHING FROM THE LOADING CATHETER]. THIS OCCURRED PRIOR TO PATIENT CONTACT. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745671 ↗
• MalfunctionNov 1, 2024Material Separation; Detachment of Device or Device Component; Misassembly by Users; Material Separation; Detachment of Device or Device Component; Misassembly by Users

  DURING A LIGATION PROCEDURE, THE PHYSICIAN SELECTED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT BOTH ENDS OF THE LOADING CATHETER WERE TORN OFF THE THREAD RETRACTION. WHEN THE CORD WAS PULLED THROUGH THE WORKING CHANNEL, BOTH ENDS [BLUE HOOKS] OF THE [LOADING] CATHETER CAME LOOSE IN THE WORKING CHANNEL. THIS HAPPENED IN THE MIDDLE OF THE WORKING CHANNEL AND NOT AT THE EXIT FROM THE VALVE. ANOTHER 6-SHOOTER HAD TO BE OPENED TO COMPLETE THE INVESTIGATION. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588582 ↗
• MalfunctionOct 25, 2024Failure to Fire; Failure to Fire

  DURING A LIGATION PROCEDURE, THE PHYSICIAN USED A COOK 6 SHOOTER SAEED MULTI-BAND LIGATOR. IT WAS REPORTED THAT DURING THE PROCEDURE, "DISADAPTATION OF THE DISPOSITIVE BEFORE JETTISONING THE 1ST ELEMENT (THE PRACTITIONER BEGAN TO TURN THE KNOB)" [UNABLE TO EFFECTIVELY DEPLOY BANDS]. THIS LED TO THE USE OF A NEW DEVICE AND PROLONGED THE INTERVENTION [PROCEDURE] BY ABOUT 15 MINUTES. AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535902 ↗