Enseal NSEAL545RHRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705036000051), received between Jul 18, 2017 and Jan 27, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AN INDIRECT CUSTOMER SENT US PHOTOS OF A PRODUCT THAT WAS SOLD TO HIM AT A MUCH LOWER PRICE THAN THE DISTRIBUTOR QUOTED HIM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21240941 ↗
• MalfunctionSep 19, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP COLECTOMY, THE JAWS WERE STUCK CLOSED WITH TISSUE IN THEM. NO PATIENT CONSEQUENCE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15450631 ↗
• MalfunctionMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  SEE ATTACHED MEDWATCH REPORT NUMBER MW5109001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14516277 ↗
• MalfunctionDec 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A DEVICE FAILURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932736 ↗
• MalfunctionDec 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS A DEVICE FAILURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929000 ↗
• MalfunctionSep 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE TIP WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12506810 ↗
• MalfunctionJun 8, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A DUODENAL SWITCH THE JAWS WOULD NOT OPEN AND CLOSE PROPERLY. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11960064 ↗
• MalfunctionApr 30, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED DURING A BARIATRIC PROCEDURE THE JAW BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED AND THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11753333 ↗
• MalfunctionAug 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A COLON PROCEDURE THE TIP OF THE DEVICE BROKE OFF AND FELL INTO THE PATIENT. THE TIP WAS FOUND VISUALLY AND RETRIEVED. THE GENERATOR DID NOT ALARM OF GIVE ANY INDICATION THAT THE TIP HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10358106 ↗
• MalfunctionApr 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT MEET THE CUSTOMER¿S EXPECTATIONS. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. IT IS UNKNOWN IF THERE WERE ANY ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911193 ↗
• MalfunctionMar 5, 2020Break

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, THE TIP OF THE DEVICE BROKE OFF. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9795837 ↗
• MalfunctionJul 25, 2019Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, PART OF THE JAW BROKE OFF INSIDE THE PATIENT. THE PIECE OF THE JAW WAS FOUND. IT IS UNKNOWN HOW IT WAS FOUND. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828958 ↗
• MalfunctionMay 24, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING AN ROBOTIC HYSTERECTOMY THE JAW CAME OFF. THE JAW WAS RETRIEVED. A SECOND LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7543013 ↗
• MalfunctionMay 11, 2018Break

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED ROUX-EN-Y, "THE TIP BROKE OFF". THE PATIENT WAS X-RAYED AND THE TIP WAS FOUND INSIDE THE TROCAR. AN ALTERNATE LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508662 ↗
• MalfunctionApr 30, 2018Break; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE; ¿WHILE DIVIDING THIS THICKENED OMENTAL ADHESION, I NOTICED THAT THE DEVICE WAS NOT FUNCTIONING PROPERLY AND FURTHER INSPECTION REVEALED THAT ONE OF THE JAWS WAS BROKEN. I TRIED TO REMOVE THE DEVICE BUT, UNFORTUNATELY, THE BROKEN JAW DID NOT COME OUT AND WE THOUGHT IT HAD GOT INTO THE PERITONEAL CAVITY. AT THIS POINT, I CALLED FOR FLUOROSCOPY TO HELP WITH LOCATING THE METAL PIECE WHICH IS A PORTION OF THE JAW OF THE DEVICE, WHICH WAS MISSING FROM THE INSTRUMENT. USING FLUOROSCOPY, THE ENTIRE ABDOMEN WAS SCANNED AND WE DID NOT FIND ANYTHING IN THE ABDOMEN AND FINALLY WHEN WE SCANNED THE TROCARS, THE SMALL METAL PIECE WAS LODGED IN ONE OF THE TROCARS IN THE LEFT FLANK. I THEN REMOVED THE TROCARS AND RETRIEVED THE METAL PIECE OUT OF THE TROCAR. THE TROCAR WAS THEN REPLACED AND WE PROCEEDED WITH THE REST OF OUR OPERATION. THE OMENTAL ADHESIONS WERE TAKEN DOWN WITH ANOTHER NEW DEVICE.¿ THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7471999 ↗
• InjuryJul 18, 2017Device Inoperable

  DURING THE PROCEDURE, THE ENSEAL 45CM STOPPED WORKING. IT WAS IMMEDIATELY REPLACED AND THERE WAS NO HARM TO THE PT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6724624 ↗