Visiport Plus 176673PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521080645), received between Dec 14, 2017 and Apr 26, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  ACCORDING TO THE REPORTER, DURING A DIAGNOSTIC LAPAROSCOPY, WHILE ACCESSING STEP OF THE PROCEDURE, THE KNIFE WOULD NOT ERECT AND CUT, RESULTING IN DIFFICULTY TO ACCESS THE PATIENT CAVITY. IT WAS NOTED THAT THE SURGERY WAS EXTENDED BY 30 MINUTES OR MORE. THE SURGEON HAD REQUESTED ANOTHER DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213015 ↗
• MalfunctionJun 27, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT ADRENALECTOMY, WHILE THEY INSERTED THE DEVICE, THE SURGEON NOTICED THAT A SMALL PIECE OF PLASTIC HAD BROKEN OFF OF THE PORT. IT WAS ON THE DRAPES, REMOVED AND TAKEN OFF THE FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7641709 ↗
• MalfunctionJun 8, 2018Device Packaging Compromised; Device Packaging Compromised

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE KNIFE WAS NOT DIFFICULT TO ADVANCE, THE LENS DID NOT DISENGAGE AND THE SEAL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7584021 ↗
• MalfunctionJun 5, 2018Detachment Of Device Component

  WHILE INSERTING THE VISIPORT, SURGEON NOTICED THAT A SMALL PIECE OF PLASTIC HAD BROKEN OFF OF THE PORT. IT WAS ON THE DRAPES, REMOVED AND TAKEN OFF OF THE FIELD. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, VISIPORT PLUS (PER SITE REPORTER): UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7568664 ↗
• MalfunctionMay 24, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ADRENALECTOMY, WHILE BEING APPLIED FOR THE INITIAL TROCAR ENTRY, THE PLASTIC LENS OF THE DEVICE FELL INTO THE PATIENT CAVITY BUT WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7541550 ↗
• MalfunctionDec 27, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, AS THE DOCTOR PLACED THE DEVICE IN PATIENT, WHILE ON THE ABDOMEN AND RETRACTED THE TROCAR, THE DEVICE¿S PIECES WERE MISSING AND SHATTERED IN THE PATIENT. IN ORDER TO RESOLVE THE ISSUE, THE TEAM BEGAN SEARCHING THE PIECES AND EVENTUALLY WERE ABLE TO LOCATE THE BROKEN PIECES. NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7148331 ↗
• InjuryDec 21, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY LAPAROSCOPIC PROCEDURE, THE DEVICE¿S LENS WAS DISENGAGED WHILE BEING APPLIED ON PLACEMENT OF TROCARS. THE SURGEON INFLATED CAVITY USING NORMAL NEEDLE INSUFFLATION. HE WAS FIRING THE TROCAR THROUGH THE MID FASCIA WITH NO DIFFICULTIES WITH NO PRIOR INCISION AND NO MESH INVOLVED. AS OBTURATOR AND CAMERA WERE REMOVED FROM THE SLEEVE, IT WAS NOTICE THAT TWO WIRE GUIDES SPRUNG OPEN ON THE SIDE OF THE OBTURATOR. IT WAS ALSO NOTICE THAT THE GLASS AT THE END OF THE OBTURATOR WAS MISSING. THEY INSPECTED INSIDE THE CAVITY SHOWED TWO PIECES OF BROKEN GLASS THAT WERE REMOVED LAPAROSCOPICALLY. A THIRD PIECE OF GLASS WAS FOUND ATTACHED TO THE FASCIA AND WAS REMOVED LAPAROSCOPICALLY. ALSO SEVERAL VERY SMALL PRICES OF METAL WERE SEEN AND REMOVED LAPAROSCOPICALLY. THE BLADE HOWEVER WAS NOT VISIBLE. THE SITE WAS EXTENDED SLIGHTLY IN ORDER TO LOOK FOR THE BLADE WITHIN THE ABDOMINAL TISSUE. THREE X-RAYS COVERING THE FULL ABDOMEN WERE TAKEN WITH NO INDICATION OF THE METAL BLADE. ULTIMATELY THE BLADE WAS FOUND ON THE FLOOR OF THE NURSE. SURGERY TIME WAS EXTENDED BY 120 MINUTES. PROCEDURE WAS COMPLETED NORMALLY USING A BLUNT TIP TROC AR IN PLACE OF THE

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 7140605 ↗
• MalfunctionDec 14, 2017Material Fragmentation

  MD WAS PLACING THE VISIPORT TROCAR IN PATIENT. WHEN MD ENTERED THE ABDOMEN AND RETRACTED THE TROCAR, IT WAS NOTED THAT THE TROCAR WAS MISSING PIECES AND SHATTERED IN THE PATIENT. TEAM BEGAN SEARCHING FOR THE PIECES AND EVENTUALLY WERE ABLE TO LOCATE THE BROKEN PIECES.

  Patient problems: No Information

  MAUDE report 7118520 ↗