Spacemaker PlusRecalls & reported problems across all models

We found 4 models of Spacemaker Plus by Covidien LP in the FDA's device registry (GUDID). Together they are named in 399 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2016 and Jul 1, 2022 — classified as 7 injuries, 392 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (171 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

Most reported Spacemaker Plus problems

Spacemaker Plus models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Spacemaker Plus SMBTTRND

  Laparoscope, general & plastic surgery
  211 reports
• Spacemaker Plus SMBTTOVL

  Laparoscope, general & plastic surgery
  112 reports
• Spacemaker Plus SMSBTOVL

  Laparoscope, general & plastic surgery
  59 reports
• Spacemaker Plus SMSBTRND

  Laparoscope, general & plastic surgery
  17 reports

Recent Spacemaker Plus adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA REPAIR, DURING INSERTION OF THE DEVICE THROUGH THE TROCAR, THE BALLOON WERE DAMAGED. THE BALLOON WAS TORN OPEN DURING WELDING SEAM. THE BALLOON ALSO DISENGAGED FROM THE TROCAR OR SLEEVE. HENCE, THE DEVICE COULD NOT BE INFLATED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14887787 ↗
• MalfunctionJun 30, 2022Inflation Problem; Decrease in Pressure; Gas/Air Leak; Inflation Problem; Decrease in Pressure; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR BY TOTAL EXTRA PERITONEAL TECHNIQUE, AT MOMENT TO INFLATE THE BALLOON, THE DEVICE DID NOT INFLATE. THE BALLOON LEAKED GAS/AIR. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE NOTED. THE OPERATOR USED ANOTHER DEVICE OF THE SAME LOT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880813 ↗
• MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE PULLING OUT THE BALLOON, THE BALLOON CAME OFF AND WAS PLACED IN THE RETROPERITONEAL CAVITY. IT DID NOT LOOK LIKE IT GOT CAUGHT AND NO RESISTANCE WAS FELT. THE REMAINING BALLOON WAS PULLED OUT USING FORCEPS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13980479 ↗
• InjuryMar 31, 2022Difficult to Insert; Material Deformation; Packaging Problem; Difficult to Insert; Material Deformation; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, WHILE INSERTING THE BALLOON, THE BALLOON WAS DIFFICULT TO INSERT INTO THE PATIENT. THE SURGEON EXTENDED THE INCISION FOR LESS THAN AN INCH AND INSERTED THE DEVICE WITH FORCE TO RESOLVE THE ISSUE. THIS RESULTED TO THE PATIENT HAVING A TISSUE DAMAGE, PERMANENT LARGER SCAR. A PROBLEM WITH THE INNER PACKAGING OF THE DEVICE WAS ALSO NOTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13966236 ↗
• MalfunctionMar 8, 2022Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA SURGERY, THE FIRST BALLOON WAS TORN AND DID NOT INSUFFLATE AND THE SECOND BALLOON HAD A HOLE AND DID NOT INFLATE. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13693614 ↗
• MalfunctionMar 8, 2022Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA SURGERY, THE FIRST BALLOON WAS TORN AND DID NOT INSUFFLATE AND THE SECOND BALLOON HAD A HOLE AND DID NOT INFLATE. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13693514 ↗
• MalfunctionFeb 8, 2022Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE BALLOON DEFLATED.

  Patient problems: Insufficient Information

  MAUDE report 13485316 ↗
• MalfunctionFeb 3, 2022Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446676 ↗
• MalfunctionJan 20, 2022Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, WHEN INSERTING THROUGH TROCAR AND INFLATION OF THE DISSECTING BALLOON, THE DEVICE DID NOT INFLATE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13306509 ↗
• MalfunctionJan 12, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE BALLOON OF THE ACCESS CANNULA IS FOUND TORN. A NEW PRODUCT WAS USED AND THE SURGERY WAS PERFORMED WITHOUT ANY PROBLEMS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235889 ↗
• MalfunctionDec 30, 2021Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE DEVICE BURST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118077 ↗
• MalfunctionDec 29, 2021Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, WHILE EXPANDING THE ABDOMINAL CAVITY WITH THE BALLOON, THE DEVICE DID NOT INFLATE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112501 ↗
• MalfunctionDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SEAL DISENGAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010065 ↗
• MalfunctionDec 10, 2021Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATECTOMY PROCEDURE, WHILE INITIATING OF PROCEEDINGS, THERE WAS A HOLE IN THE BALLOON. THE BALLOON DID NOT INFLATE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12976109 ↗
• MalfunctionDec 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE BALLOON DISENGAGED FROM THE TROCAR OR SLEEVE. THE TROCAR'S SILICON TIP WAS OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12941739 ↗

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