Versaport Plus NB15LGFRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521076525), received between Oct 24, 2017 and Apr 24, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SILICON COVER COMBINED WITH 5 MILLIMETER CONVERTER CAP WAS FOUND INTRA-ABDOMINALLY. THE SURGEON FOUND THE SILICON COVER BEFORE CLOSING THE ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16800968 ↗
• MalfunctionFeb 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE INNER PART OF THE PORT WHICH IS THE SEAL DISENGAGED AND FELL INTO THE PATIENT CAVITY, THE SURGEON ABLE TO RETRIEVED IT. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377935 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD DISENGAGED SEAL. AS STATED, THE DEVICE HOOK WAS BEING USED AND WHEN INTRODUCED THROUGH THE REDUCER CAP IT POPPED THE OPAQUE SEAL OFF AND IT FELL ON TOP OF THE 15 MM SEAL. HOWEVER, IT DID NOT FELL INTO THE PATIENT¿S CAVITY. THE SEAL NEVER ENTERED THE PATIENT. NO PATIENT HARM.

  Patient problems: No Patient Involvement

  MAUDE report 7359990 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD DISENGAGED SEAL. AS STATED, THE DEVICE HOOK WAS BEING USED AND WHEN INTRODUCED THROUGH THE REDUCER CAP IT POPPED THE OPAQUE SEAL OFF AND IT FELL ON TOP OF THE 15 MM SEAL. HOWEVER, IT DID NOT FELL INTO THE PATIENT¿S CAVITY. THE SEAL NEVER ENTERED THE PATIENT. PATIENT HAD NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7358241 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD DISENGAGED SEAL. AS STATED, THE DEVICE HOOK WAS BEING USED AND WHEN INTRODUCED THROUGH THE REDUCER CAP IT POPPED THE OPAQUE SEAL OFF AND IT FELL ON TOP OF THE 15 MM SEAL. HOWEVER, IT DID NOT FELL INTO THE PATIENT¿S CAVITY. THE SEAL NEVER ENTERED THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357990 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD DISENGAGED SEAL. AS STATED, THE DEVICE HOOK WAS BEING USED AND WHEN INTRODUCED THROUGH THE REDUCER CAP IT POPPED THE OPAQUE SEAL OFF AND IT FELL ON TOP OF THE 15 MM SEAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357467 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD DISENGAGED SEAL. AS STATED, THE DEVICE HOOK WAS BEING USED AND WHEN INTRODUCED THROUGH THE REDUCER CAP IT POPPED THE OPAQUE SEAL OFF AND IT FELL ON TOP OF THE 15 MM SEAL. HOWEVER, IT DID NOT FELL INTO THE PATIENT¿S CAVITY. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357421 ↗
• MalfunctionMar 21, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD A DISENGAGED SEAL. THE 5MM REDUCER CAP WAS BEING USED OVER THE 15MM PORT. THE HOOK WAS BEING USED AND WHEN INTRODUCED THROUGH THE REDUCED CAP, IT POPPED THE OPAQUE SEAL OFF AND IT FELL ON TOP OF THE 15MM SEAL. IT DID NOT FALL INTO THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7357379 ↗
• MalfunctionOct 24, 2017Detachment Of Device Component; Leak/Splash; Noise, Audible; Detachment Of Device Component; Leak/Splash; Noise, Audible

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE. THE PORT WAS PLACED INTO THE PATIENT. THE SURGEON WAS USING 5MM INSTRUMENTS THROUGH THE REDUCER CAP AND OPENING / CLOSING AS NEEDED FOR 10MM OR 15MM INSTRUMENTS / STAPLERS. EARLY ON IN THE CASE, NOTED MORE THAN USUAL SOUND OF ESCAPING GAS FROM PORT. CHECKED VALVES ON TROCARS NOT CONNECTED TO INSUFFLATION, ALL PORTS CLOSED. THERE WAS NO LEAKING NOTED AT THE TROCAR INCISION SITES. SHORTLY THEREAFTER (UNDER LAPAROSCOPIC VIEW), THE SURGEON OBSERVED A CIRCULAR OPAQUE WHITE FOREIGN OBJECT IN THE ABDOMEN. EXAMINED THE 5-15MM CAP AND DISCOVERED THAT THE SEAL WAS ABSENT FROM THE CAP. THE 5-15 MM SEAL DISENGAGED AND FELL INTO THE CAVITY OF THE PATIENT. THE SURGEON WAS ABLE TO RETRIEVE THE SEAL. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, REPLACED WITH A NEW 5-15MM REDUCER CAP. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS ALIVE, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6971696 ↗