Maxon 8886 6219-33Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884523002355), received between Sep 21, 2017 and Aug 27, 2021 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K990951); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC COLECTOMY WHILE ON WOUND CLOSURE, THERE WERE ONLY FOUR SUTURES INSTEAD OF FIVE INSIDE THE PACKET. TO RESOLVE THE ISSUE, A NEW PRODUCT FROM DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380420 ↗
• MalfunctionFeb 24, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING RECTAL LAPAROSCOPY/LAPAROSCOPIC RECTAL RESECTION/AMPUTATION, THE VICINITY OF THE YARN PORTION HAS BEEN DAMAGED WHEN GRASPING THE VICINITY OF THE YARN PORTION OF THE NEEDLE IN THE ABDOMINAL CAVITY BEFORE THE NEEDLE WITH A HOLDING NEEDLE. SINCE THE NEW PRODUCT WAS OPENED AND USED WITHOUT ANY PROBLEMS. PART OF THE DEVICE FELL INTO THE PATIENT'S CAVITY BUT WAS RETRIEVED WITH FORCEPS. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744112 ↗
• MalfunctionOct 7, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING BYPASS OF GASTROENTEROSTOMY, THE NEEDLE BROKE AT THE FIRST STITCH, THE BROKEN NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9161765 ↗
• InjurySep 4, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE SIXTH STITCH OF SUTURING DURING LAPAROSCOPIC TOTAL GASTRECTOMY, THE NEEDLE BROKE AND FELL INTO THE PATIENT¿S CAVITY. IT WAS STATED THAT THE NEEDLE WAS RETRIEVED AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Code Available

  MAUDE report 8960414 ↗
• InjuryDec 27, 2018Break; Break

  ACCORDING TO THE REPORTER, THE CASE WAS PLANNED FOR LAPAROSCOPIC CHOLECYSTECTOMY, BUT IT WAS CONVERTED TO OPEN CHOLECYSTECTOMY. WHEN PERFORMING GALLBLADDER COLECTOMY AND SUTURING THE WALL OF THE BILIARY WALL, AT THE END OF THE HANDLING OF THE NEEDLE, WHILE HOLDING THE NEEDLE TIP AND THE THREAD AND TRYING TO DETACH THE NEEDLE, THE NEEDLE BROKE. THE DEVICE FELL ONTO THE PATIENT CAVITY AND WAS RETRIEVED.

  Patient problems: No Code Available

  MAUDE report 8199058 ↗
• MalfunctionSep 21, 2017Break; Break

  ACCORDING TO THE REPORTER, THE SURGEON SUTURED PANCREATIC PARENCHYMA AND TRIED TO DETACH THE SUTURE THREAD FROM THE NEEDLE, HOWEVER THE NEEDLE TIP WAS BROKEN. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882329 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990951. One submission often covers many models, so check the product and lot details in each record.

• Z-2542-2017 · May 3, 2017 · Terminated
  Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: