MUSE Endostapler 01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290014036062), received between Jun 29, 2017 and May 22, 2018 — classified as 5 injuries.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FUNDOPLICATION PROCEDURE WAS DONE ON (B)(6). THE NEXT DAY, THE MEDIGUS REPRESENTATIVE LEARNED THAT, SEVERAL HOURS AFTER THE PROCEDURE, THE FEMALE PATIENT HAD SEVERE CHEST PAIN. THE CT SCAN WAS ABNORMAL, INDICATING PLEURAL EFFUSION, PNEUMOMEDIASTINUM AND AN ESOPHAGEAL PERFORATION OF 1 CM. LAPAROSCOPIC SURGERY WAS DONE TO REPAIR THE PERFORATION. PATIENT WAS STABLE TWELVE HOURS AFTER SURGERY.

  Patient problems: Chest Pain; Pleural Effusion

  MAUDE report 7532326 ↗
• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS AN ACTIVE (B)(6) YEAR OLD WOMAN IN GENERAL GOOD HEALTH EXCEPT AS NOTED IN "OTHER RELEVANT HISTORY." THE PROCEDURE WAS UNEVENTFUL. ON THE DAY AFTER THE PROCEDURE, SHE COMPLAINED OF SHORTNESS OF BREATH AND RETROSTERNAL PAIN. THERE WERE NO CLINICAL SIGNS OF AN INFLAMMATORY RESPONSE BUT A CT SCAN DISCLOSED SMALL PNEUMOMEDIASTINUM AND PLEURAL EFFUSION. A CHEST DRAIN WAS PLACED AND A SMALL AMOUNT OF CLEAR FLUID WAS DRAINED. THE FLUID WAS A TRANSUDATE (PROTEIN<3). THE CHEST DRAIN WAS REMOVED ON DAY TWO AND THERE WAS NO RADIOLOGICAL EVIDENCE OF CONTINUING LEAKAGE. ALTHOUGH THE CHEST PAIN RESOLVED, THE PATIENT CONTINUED TO COMPLAIN OF EPIGASTRIC PAIN AND WAS FOUND TO HAVE A NEW DUODENAL ULCER FOR WHICH SHE IS NOW RECEIVING TREATMENT. THE PATIENT MAY HAVE DEVELOPED THE ULCER BECAUSE SHE STOPPED TAKING THE PPI SINCE SHE NO LONGER HAD GERD SYMPTOMS. THE EVENT WAS DEEMED AS PROCEDURE RELATED RATHER THAN DEVICE RELATED BY THE MEDICAL DIRECTOR FOR THE HOSPITAL. ALSO, DUE TO THE HIGH PREVALENCE OF H. PYLORI CONTAMINATION IN (B)(6), SCREENING FOR H. PYLORI COLONIZATION BEFORE THE PROCEDURE WAS STRONGLY RECOMMENDED. THE PROCEDURE CAN BE DONE AFTER ERADICATION OF H. PYLORI.

  Patient problems: Chest Pain; Pleural Effusion

  MAUDE report 7430689 ↗
• InjuryJul 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIRST DAY AFTER THE PROCEDURE WAS COMPLETED ((B)(6) 2017), THE PATIENT COMPLAINED OF SUDDEN CHEST DISCOMFORT AND FEVER (38 DEGREES CELSIUS.) SEVERAL TESTS WERE DONE TO DETERMINE THE CAUSE. THE CHEST CT SCAN SHOWED PNEUMOMEDIASTINUM AT THE LOWER ESOPHAGEAL REGION. THE PATIENT WAS TREATED WITH NEXIUM (ACID SUPPRESSION DRUG), AVELOX (ANTI-INFLAMMATORY DRUG), SULPERAZONE (INTRAVENOUS ANTIBIOTIC) AND A NASOGASTRIC TUBE WAS INSERTED. DURING THE NIGHT OF (B)(6), THE PATIENT'S SELF-REPORTED DISCOMFORT DISAPPEARED. THE PATIENT HAD NO FEVER THE SECOND DAY ((B)(6)) AND BODY TEMPERATURE DID NOT EXCEED 37.4 DEGREES. ON THE THIRD DAY ((B)(6)), THE PATIENT'S HIGHEST TEMPERATURE WAS 38.5 DEGREES CELSIUS. A SECOND CT SCAN SHOWED INFERIOR LOBE CONSOLIDATION AND BILATERAL PLEURAL EFFUSION. THERE WAS NO MEDIASTINAL EMPHYSEMA. ON THE FOURTH DAY ((B)(6)), THE PATIENT STILL HAD AN ELEVATED WHITE BLOOD CELL COUNT. ON THE FIFTH DAY ((B)(6)), THE PATIENT'S BODY TEMPERATURE RETURNED TO NORMAL. ON THE SIXTH DAY ((B)(6)), THE PATIENT HAD NO CHEST OR ABDOMINAL DISCOMFORT AND BEGAN EATING. HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), AFTER ELEVEN DAYS OF HOSPITALIZATION.

  Patient problems: Chest Pain; Fever; Pleural Effusion

  MAUDE report 6725212 ↗
• InjuryJul 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER MUSE SURGERY ON (B)(6) 2017, THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT. TEST RESULTS INDICATED THAT HE HAD DEVELOPED A PNEUMOPERITONEUM. HE WAS GIVEN GASTROINTESTINAL DECOMPRESSION TREATMENT, REHYDRATION AND MEDICATIONS TO REDUCE PAIN AND PREVENT INFECTION. THE PATIENT'S HOSPITAL STAY WAS PROLONGED DUE TO THE PNEUMOPERITONEUM. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2017.

  Patient problems: Chest Pain; No Code Available

  MAUDE report 6684898 ↗
• InjuryJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIRST DAY AFTER SURGERY ((B)(6) 2017), THE PATIENT HAD THROAT DISCOMFORT, WITH A SLIGHT DISCOMFORT OF SUBSTERNAL ESOPHAGUS AND MIDDLE & UPPER ABDOMINAL REGION. THERE WAS NO FEVER OR ABDOMINAL PAIN BUT SINCE HER BLOOD LEUCOCYTES WERE HIGH, SHE WAS PLACED ON AN INTRAVENOUS INFUSION OF CEFAZOLIN FOR ANTI-INFECTION TREATMENT. LATER, THE PATIENT DID HAVE A FEVER, THE HIGHEST TEMPERATURE BEING 38.3 DEGREES CELSIUS. THE SYMPTOMS WERE MARKED BY THROAT PAIN WITH A SLIGHT DISCOMFORT IN THE POSTERIOR ESOPHAGUS AND THE MIDDLE AND UPPER ABDOMEN AND FATIGUE. THE PATIENT REFUSED TO HAVE A CHEST AND ABDOMINAL CT DONE TO DETERMINE THE REASON FOR THE SYMPTOMS SO THE HOSPITAL CONTINUED THE ANTIBIOTICS, ANTI-INFLAMMATORY DRUGS TREATMENT, AND PPI DRUGS TO PROTECT THE STOMACH. THE FEVER LASTED FOR MORE THAN THREE DAYS; THEN THE BODY TEMPERATURE RETURNED TO NORMAL AND THE SYMPTOMS GRADUALLY DISAPPEARED. ON THE SIXTH DAY ((B)(6)), THE BLOOD TESTS WERE NORMAL. THE PATIENT REMAINED ON INTRAVENOUS ANTIBIOTICS FOR ANOTHER TWO DAYS AND THEN WAS DISCHARGED ON (B)(6) 2017.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 6677619 ↗