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N/A LF1744Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Maryland Jaw Sealer/Divider · Class 2

Adverse event reports
15
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327375800), received between May 8, 2020 and Sep 17, 2020 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Energy Output Problem15

Patient problems

  • No Clinical Signs, Symptoms or Conditions7
  • No Consequences Or Impact To Patient5
  • Blood Loss2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 17, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL DAMAGED LIGASURE DEVICES. THERE WERE ERROR CODES ON THE GENERATOR INDICATING AN INCOMPLETE SEALING CYCLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10551396 ↗
  • MalfunctionSep 17, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL DAMAGED LIGASURE DEVICES. THERE WERE ERROR CODES ON THE GENERATOR INDICATING AN INCOMPLETE SEALING CYCLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10551394 ↗
  • MalfunctionSep 17, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL DAMAGED LIGASURE DEVICES. THERE WERE ERROR CODES ON THE GENERATOR INDICATING AN INCOMPLETE SEALING CYCLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10551393 ↗
  • MalfunctionSep 17, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL DAMAGED LIGASURE DEVICES. THERE WERE ERROR CODES ON THE GENERATOR INDICATING AN INCOMPLETE SEALING CYCLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10551391 ↗
  • MalfunctionSep 17, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL DAMAGED LIGASURE DEVICES. THERE WERE ERROR CODES ON THE GENERATOR INDICATING AN INCOMPLETE SEALING CYCLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10551390 ↗
  • MalfunctionSep 17, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL DAMAGED LIGASURE DEVICES. THERE WERE ERROR CODES ON THE GENERATOR INDICATING AN INCOMPLETE SEALING CYCLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10551389 ↗
  • MalfunctionSep 17, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD SEVERAL DAMAGED LIGASURE DEVICES. THERE WERE ERROR CODES ON THE GENERATOR INDICATING AN INCOMPLETE SEALING CYCLE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10546711 ↗
  • InjuryMay 28, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. THE UTILIZATION OF HEMOSTATIC AGENTS AND/OR SURGICAL CLIP APPLIERS WAS REQUIRED. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10099459 ↗
  • InjuryMay 28, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. EXCESSIVE BLEEDING WAS SEEN. THE COMPLAINANT IS NOT AWARE OF THE VOLUME OF BLOOD LOSS. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: Blood Loss

    MAUDE report 10099409 ↗
  • InjuryMay 28, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE (B)(6) JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. THE UTILIZATION OF HEMOSTATIC AGENTS AND/OR SURGICAL CLIP APPLIERS WAS REQUIRED. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10099406 ↗
  • InjuryMay 28, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. EXCESSIVE BLEEDING WAS SEEN. THE COMPLAINANT IS NOT AWARE OF THE VOLUME OF BLOOD LOSS. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: Blood Loss

    MAUDE report 10099405 ↗
  • MalfunctionMay 27, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10093205 ↗
  • MalfunctionMay 27, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10093115 ↗
  • MalfunctionMay 27, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10093112 ↗
  • MalfunctionMay 8, 2020Energy Output Problem; Energy Output Problem

    IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10040905 ↗

Other ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED devices

All ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.