Surgiwand II 178091Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 10884523000894), received between May 22, 2017 and Sep 25, 2023 — classified as 9 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Break” (46 reports).

1 other recall cover devices cleared under the same FDA submission (K961771); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812476 ↗
• MalfunctionSep 14, 2023Break; Break

  ACCORDING TO THE REPORTER, THE TIP OF THE DEVICE WAS BROKEN. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745701 ↗
• MalfunctionAug 29, 2023Sparking; Sparking

  ACCORDING TO THE REPORTER, PREOPERATIVELY, AN UNEXPECTED SPARK WAS FOUND AND OCCURRED. AN EXCHANGE OF DEVICE WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644065 ↗
• MalfunctionJul 10, 2023Break; Sparking; Detachment of Device or Device Component; Material Twisted/Bent; Break; Sparking; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, AT CAUTERIZATION OF LIVER BED, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED AND BROKEN PIECE OF THE SHAFT FELL IN THE ABDOMEN. THE BROKEN PIECE WAS RETRIEVED USING LAPAROSCOPIC GRASPERS. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17292310 ↗
• MalfunctionDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SHAFT CAME OUT BY ITSELF. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15970987 ↗
• MalfunctionNov 8, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 15751499 ↗
• MalfunctionOct 3, 2022Melted; Melted

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA SURGERY, THE THREE DEVICES HAD MELTED PLASTIC ENDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533170 ↗
• MalfunctionOct 3, 2022Melted; Melted

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA SURGERY, THE THREE DEVICES HAD MELTED PLASTIC ENDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15532630 ↗
• MalfunctionOct 3, 2022Melted; Melted

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA SURGERY, THE THREE DEVICES HAD MELTED PLASTIC ENDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15532035 ↗
• MalfunctionAug 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, IN TWO DEVICES, ON OPENING THE HOOK, THE BLACK COVERING TIP BROKE AND GOT DAMAGED AT ONCE. THIS CREATED EDGES THAT ARE DANGEROUS. IT WAS NOTED THAT THE DEVICE WAS NOT USED ON THE TISSUE YET. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15298146 ↗
• MalfunctionAug 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, IN TWO DEVICES, ON OPENING THE HOOK, THE BLACK COVERING TIP BROKE AND GOT DAMAGED AT ONCE. THIS CREATED EDGES THAT ARE DANGEROUS. IT WAS NOTED THAT THE DEVICE WAS NOT USED ON THE TISSUE YET. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294224 ↗
• MalfunctionAug 19, 2022Sparking; Sparking

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UNEXPECTED SPARK WAS FOUND AND OCCURRED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259705 ↗
• MalfunctionAug 10, 2022Melted; Melted

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, BEFORE USING THE DEVICE ON THE PATIENT, THE DEVICE MELTED.

  Patient problems: Insufficient Information

  MAUDE report 15200980 ↗
• MalfunctionAug 10, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLE PROCEDURE, AFTER INSERTING THE DEVICE THROUGH THE PORT, IT WAS SEEN ON THE SCREEN THAT THE SHEATH WAS DAMAGED. IMMEDIATELY AFTER THE DEFECT WAS NOTICED, THE DEVICE WAS REMOVED OFF THE FIELD AND ANOTHER INSTRUMENT WAS OPENED TO RESOLVE THE ISSUE. THE PATIENT IS CURRENTLY DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200754 ↗
• MalfunctionJun 7, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHILE PREPARING CASE, THE ITEM WAS FOUND FAULTY (CRACKED) AT THE BLACK PLASTIC TIP WHEN REMOVE FROM THE PACKAGING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622838 ↗
• MalfunctionMay 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SURGEON TRIED TO PRESS THE BUTTON, BUT THE BUTTON WAS PULLED OUT AND COULD NOT BE USED.

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

  MAUDE report 14269851 ↗
• MalfunctionMar 31, 2022Break; Device Slipped; Break; Device Slipped

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC PROCEDURE, THE SHEATH CAME OFF. A NEW PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966178 ↗
• MalfunctionFeb 24, 2022Break; Break

  ACCORDING TO THE REPORTER PRIOR USE OF DEVICE TO A PROCEDURE THERE WAS A DAMAGED NOTICED ON THE SHEATH OF THE DEVICE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589389 ↗
• MalfunctionFeb 23, 2022Sparking; Sparking

  ACCORDING TO THE REPORTER PRIOR USE TO A PROCEDURE, THE DEVICE HAD AN UNEXPECTED SPARK FOUND AND NOTICED. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585209 ↗
• MalfunctionFeb 16, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. THE TIP OF THE INSTRUMENT BECAME DEFORMED AFTER ONLY A FEW MINUTES USED AND WITHOUT ANY EXCESSIVE FORCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542197 ↗
• MalfunctionDec 13, 2021Break; Melted; Break; Melted

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC LOWER ANTERIOR RESECTION, THE SURGEON WAS USING THE DEVICE IN THE PROCESS OF REMOVING THE MESENTERIC, BUT THE INSULATING PLASTIC SURROUNDING THE TIP SUDDENLY BURNED, SO HE TOOK IT OUT OF THE BODY AND CHECKED THAT THE END WAS SLIGHTLY MELTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987307 ↗
• MalfunctionNov 16, 2021Sparking; Sparking

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UNEXPECTED SPARK WAS FOUND AND OCCURRED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822047 ↗
• MalfunctionNov 16, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE DISTAL TIP OF THE SHEATH WAS DAMAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12818087 ↗
• MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, IT WAS FOUND THAT THE TIP OF THE DEVICE WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12778789 ↗
• MalfunctionOct 22, 2021Break; Melted; Break; Melted

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED AND WAS MELTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683411 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961771. One submission often covers many models, so check the product and lot details in each record.

• Z-1411-2021 · Mar 5, 2021 · Open, Classified
  Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094