SMARTSTITCH OM-8000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817470001679), received between Sep 17, 2020 and Jan 5, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Activation Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K123268); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SMARTSTITCH UPPER JAW WAS NOT FUNCTIONING, THE DEVICE WAS NOT ACTIVATING THE METAL PRONGS TO SHOOT THE SUTURE CARTRIDGES INTO THE ROTATOR CUFF TISSUE. THERE WAS NO A SIGNIFICANT DELAY. THE PROCEDURE WAS PERFORMED BY USING A DIFFERENT TECHNIQUE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11116202 ↗
• InjuryDec 28, 2020Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING SET UP FOR A ROTATOR CUFF REPAIR SURGERY, THE "OPUS SMARTSTITCH GUN" COULD NOT ACTIVATE THE METAL PRONGS TO SHOOT THE SUTURE CARTRIDGES INTO THE ROTATOR CUFF TISSUE AND THE UPPER JAW DID NOT FUNCTION. ADDITIONALLY, THE DEVICE DID NOT HAVE A VISIBLE SERIAL NUMBER, IT IS SO OLD THAT IT HAD WORN OFF AND WAS UNREADABLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED CHANGING THE SURGICAL TECHNIQUE (MAYO NEEDLES) WITHOUT SIGNIFICANT DELAY. NO FURTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078204 ↗
• InjurySep 17, 2020Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING SURGERY, THE SUTURE OF THE SMARTSTITCH WOULD NOT DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A DIFFERENT TECHNIQUE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10545897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123268. One submission often covers many models, so check the product and lot details in each record.

• Z-3000-2020 · Feb 21, 2019 · Terminated
  Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971