Minerva Single Sterile Disposable Handpiece MIN9770Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00862393000162), received between Feb 1, 2016 and Jul 29, 2026 — classified as 75 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (31 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. 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 98 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the final seconds (around 110-112 seconds) of a Minerva endometrial ablation procedure, a bubbling or gurgling sound was noted. Per the physician, the controller released gas, followed by hot fluid leaking from the cervix. This fluid caused a superficial, first-degree burn to an area of the vaginal mucosa adjacent to the cervix.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 50074376 ↗
• MalfunctionApr 22, 2026

  MINERVA HANDPIECE ERROR CODE 002 OCCURRED WITH 59 SECONDS REMAINING OUT OF 120 SECOND BURN TIME. REPLACED WITH NEW HANDPIECE. LOT 25F09-04 REF: MIN9770 EXP: 06/09/2027.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953015 ↗
• MalfunctionFeb 23, 2026

  CASE: ENDOMETRIAL ABLATION, WITH HYSTEROSCOPY AND D&C [DILATION AND CURETTAGE]. USING THE MINERVA, ERROR 010 (ARGON FLOW RELATED ERROR; REPLACE WITH NEW DISPOSABLE HAND PIECE) SHOWED ON SCREEN. MALFUNCTION HAND PIECE INFORMATION (REF MIN9770, LOT 25F17-01, EXP 2027-06-17) SURGICAL TEAM REPLACED HAND PIECE IN REAL TIME. PROCEEDED WITH CASE AS PLANNED, NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413576 ↗
• InjuryJan 7, 2026Use of Device Problem

  IT WAS REPORTED THAT THE TREATING PHYSICIAN HAD DIFFICULTY WITH THE DILATION OF THE ENDOCERVICAL CANAL. THE PHYSICIAN WAS REPORTED TO HAVE DILATED THE PATIENT TO 7 AND ATTEMPTED TO INSERT THE MINERVA DEVICE INTO THE UTERINE CAVITY. THE TENACULUM WAS REPORTED TO HAVE SLIPPED, WHICH CAUSED THE MINERVA DEVICE TO ENTER THE CAVITY, RESULTING IN A UTERINE PERFORATION. THE DOCTOR CONFIRMED THE PERFORATION VIA HYSTEROSCOPY AND CONVERTED TO HYSTERECTOMY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 23991492 ↗
• InjuryDec 5, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A MINERVA PROCEDURE WAS PERFORMED IN AN EARLY 40S-YEAR-OLD PATIENT WITH NO PRIOR SURGERIES OR IFU CONTRAINDICATIONS. DIAGNOSTIC HYSTEROSCOPY WAS PERFORMED, AND THE UTERINE CAVITY APPEARED TO BE OF NORMAL SIZE WITH NO EVIDENCE OF PATHOLOGY. THE UTERUS WAS SOUNDED AND MEASURED TO ~ 10 CM, THE CERVICAL CANAL WAS MEASURED USING THE MINERVA DILATOR TO 5CM, AND THE MINERVA DEVICE WAS SET TO 5 CM. THE CERVICAL CANAL WAS DILATED TO 8 MM USING A SET OF HEGAR DILATORS, AND THE MINERVA DEVICE WAS INSERTED AND DEPLOYED. DR. INDICATED THAT THE ARRAY OPENING BLACK INDICATOR LINE WAS JUST ABOVE THE BORDER BETWEEN THE RED/GREEN ZONE. THE PHYSICIAN CLOSED, REMOVED, AND REINSERTED THE DEVICE. ON THE SECOND ATTEMPT, THE INDICATOR WAS JUST ABOVE THE RED ZONE, AT THE BEGINNING OF THE GREEN. DR. DECIDED TO MOVE FORWARD WITH THIS CASE. THE CERVICAL BALLOON WAS INFLATED. UIT WAS INITIATED AND PASSED ON THE FIRST ATTEMPT, WHICH WAS FOLLOWED BY AN UNINTERRUPTED 120-SECOND ABLATION CYCLE. THE CERVICAL BALLOON WAS DEFLATED. THE MINERVA DEVICE WAS UNLOCKED AND REMOVED. POST-ABLATION HYSTEROSCOPY WAS PERFORMED, AND DR. OBSERVED TWO DEFECTS THAT INDICATED POSSIBLE UTERINE WALL PERFORATION. D

  Patient problems: Bowel Burn; Uterine Perforation

  MAUDE report 23728340 ↗
• InjuryNov 17, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A MINERVA PROCEDURE WAS PERFORMED IN A 35-YEAR-OLD PATIENT WITHOUT PRIOR GYNECOLOGIC SURGERIES. UTERINE SOUNDING WAS PERFORMED FIRST, AND THE DOCTOR SUSPECTED A UTERINE PERFORATION. HYSTEROSCOPY WAS PERFORMED; HOWEVER, THE DOCTOR WAS UNABLE TO VISUALIZE A PERFORATION. THE INITIAL SOUNDING LENGTH WAS MEASURED AT 7-CM, BUT AFTER THE SUSPECTED PERFORATION, IT READ 9-CM. THIS VALUE WAS USED TO CALCULATE THE LENGTH SETTING FOR THE MINERVA DEVICE. DILATION OF THE CERVICAL CANAL WAS PERFORMED; THE EXACT DEGREE OF DILATION UNKNOWN, THEN THE MINERVA DEVICE WAS INSERTED AND DEPLOYED. EXACT DEGREE OF DEVICE DEPLOYMENT IS UNKNOWN. THE CERVICAL BALLOON WAS INFLATED WITH 3CC OF AIR, AND UIT WAS INITIATED BUT FAILED. THE DOCTOR SUSPECTED A CERVICAL LEAK AND ADDED AN ADDITIONAL 3CC OF AIR. UIT WAS INITIATED FOR THE SECOND TIME AND FAILED. THERE WERE NO BUBBLES OR HISSING SOUNDS OBSERVED AT THE TIME OF THE FIRST OR SECOND UIT. THE DOCTOR ADDED ANOTHER 3CC OF AIR, AND UIT WAS INITIATED A THIRD TIME AND PASSED, WHICH WAS FOLLOWED WITH 120 SECONDS OF UNINTERRUPTED THERAPY CYCLE. UPON COMPLETION, THE BALLOON WAS DEFLATED, DEVICE UNLOCKED, CLOSED, AND REMOVED. POST-ABLATION HYSTEROS

  Patient problems: Bowel Burn; Bowel Perforation; Uterine Perforation

  MAUDE report 23577356 ↗
• InjuryOct 17, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT A MINERVA PROCEDURE WAS PERFORMED IN A 39 YEARS OLD PATIENT WITH A HISTORY OF ONE CESAREAN DELIVERY, A LAPAROSCOPIC MYOMECTOMY OF A 9-CM SUBSEROSAL, PEDUNCULATED FIBROID, AND A VAGINAL DELIVERY. DIAGNOSTIC LAPAROSCOPY WAS PERFORMED FIRST. HYSTEROSCOPY WAS PERFORMED AND NO PATHOLOGY WAS SEEN. THE AXIS OF THE UTERUS WAS RETROFLEXED. DILATION OF THE CERVICAL CANAL WAS PERFORMED USING A SET OF HEGAR DILATORS, EXACT DEGREE OF DILATION UNKNOWN. THE MINERVA DILATOR WAS NOT USED. DUE TO SEVERITY OF RETROFLEXION, THE DR. INDICATED THAT TO ACCOMMODATE INSERTION OF THE MINERVA DEVICE, THE CERVICAL CANAL HAD TO BE OVER-DILATED. THE MINERVA DEVICE WAS INSERTED AND DEPLOYED. EXACT DEGREE OF DEVICE DEPLOYMENT IS UNKNOWN, BUT DR. INDICATED THAT IT WAS JUST PAST THE RED ON THE RED/GREEN INDICATOR OF THE DEVICE. THE CERVICAL BALLOON WAS INFLATED, BUT THE RED/GREEN INDICATOR ON THE CONTROLLER STAYED IN RED. DR. ASSUMED A CO2 LEAK AT THE CERVIX AND APPLIED A SECOND TENACULUM. WHEN THIS DID NOT RESOLVE THE PROBLEM, DR. SUSPECTED THAT APPLICATION OF THE SECOND TENACULUM COULD HAVE PERFORATED THE BALLOON. THE MINERVA DEVICE WAS UNLOCKED AND REMOVED. THE BALLOON WAS INSPECTED AND FOUN

  Patient problems: Abdominal Pain; Bowel Burn; Bowel Perforation; Uterine Perforation

  MAUDE report 23323133 ↗
• InjurySep 16, 2025Use of Device Problem; Use of Device Problem

  TREATING PHYSICIAN ATTEMPTED A MINERVA ES ABLATION PROCEDURE AND UPON INSERTING THE HANDPIECE, FELT THAT A PERFORATION HAD LIKELY OCCURRED. PHYSICIAN REMOVED THE HANDPIECE, PERFORMED A HYSTEROSCOPY, AND CONFIRMED A PERFORATION ON THE RIGHT SIDE OF THE FUNDUS. THE PATIENT WAS TRANSFERRED TO A HOSPITAL TO BE MONITORED. LAPAROSCOPIC EVALUATION OF THE PERFORATION SITE WAS PERFORMED. BIPOLAR COAGULATION WAS USED TO CONTROL MINOR CAPILLARY "OOZING", AND THE PATIENT WAS DISCHARGED.

  Patient problems: Uterine Perforation

  MAUDE report 23067169 ↗
• InjuryAug 4, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT POST A LAPAROSCOPIC SALPINGECTOMY, THE TREATING PHYSICIAN ATTEMPTED AN ENDOMETRIAL ABLATION USING A MINERVA ES DEVICE. THE UTERINE INTEGRITY TEST (UIT) WAS ATTEMPTED TWICE AND FAILED BOTH TIMES. THE TREATING PHYSICIAN RE-ENTERED ONE OF THE EXISTING LAPAROSCOPIC PORTS TO VISUALIZE THE UTERUS WHERE A UTERINE PERFORATION WAS OBSERVED. A DECISION WAS MADE TO PROPHYLACTICALLY USE AN ABSORBABLE HEMOSTATIC POWDER ON THE PERFORATION AND THE ABLATION WAS ABORTED.

  Patient problems: Uterine Perforation

  MAUDE report 22699650 ↗
• InjuryJun 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 A MINERVA ENDOMETRIAL ABLATION PROCEDURE WAS PERFORMED ON A PATIENT SUFFERING FROM AUB AND SUSPECTED ADENOMYOSIS. THE HANDPIECE WAS INSERTED, PASSED THE UTERINE INTEGRITY TEST (UIT) AND PERFORMED THE FULL ABLATION CYCLE. POST ABLATION HYSTEROSCOPY WAS ATTEMPTED; HOWEVER, DISTENTION COULD NOT BE OBTAINED. DIAGNOSTIC LAPAROSCOPY WAS PERFORMED AND CONFIRMED A PERFORATION ABOUT 1 CM FROM THE RIGHT CORNU. SUPERFICIAL BURNS WERE IDENTIFIED ON THE SIGMOID COLON AND RIGHT URETER AND IT WAS DETERMINED NO SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS KEPT OVERNIGHT FOR MONITORING AND WENT HOME THE NEXT DAY.

  Patient problems: Bowel Burn; Uterine Perforation

  MAUDE report 22194402 ↗
• InjuryMay 1, 2025Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device Problem

  IT WAS REPORTED THAT IN (B)(6) 2024 (EXACT DATE UNKNOWN) A MINERVA ENDOMETRIAL ABLATION PROCEDURE WAS PERFORMED IN A PATIENT SUFFERING FROM AUB AND BACTERIAL VAGINOSIS. FOLLOWING AN UNEVENTFUL ABLATION PROCEDURE, THE PATIENT DEVELOPED ENDOMETRITIS AND UNDERWENT A HYSTERECTOMY.

  Patient problems: Unspecified Infection

  MAUDE report 21942659 ↗
• InjuryMay 1, 2025Use of Device Problem; Use of Device Problem

  ON APRIL 4, 2025 IT WAS REPORTED THAT A MINERVA ENDOMETRIAL ABLATION PROCEDURE WAS PERFORMED ON (B)(6) 2025. ONE TO TWO DAYS AFTER THE ABLATION PROCEDURE THE PATIENT RETURNED TO THE DOCTOR WITH SEVERE ABDOMINAL PAIN. LAPAROTOMY REVEALED A UTERINE PERFORATION ON THE POSTERIOR UTERINE WALL AND THERMAL DAMAGE TO THE SMALL BOWEL. SUBSEQUENTLY MINERVA SURGICAL RECEIVED MW5168793 ON APRIL 23, 2025 FROM FDA. THE MEDWATCH REPORT REPRESENTS THE SAME EVENT. PER MEDWATCH, "PATIENT FOUND TO HAVE PERFORATED BOWELS AND UTERUS AND BURNS TO UTERUS, FALLOPIAN TUBES, AND BOWELS." SMALL BOWEL RESECTION WITH END-TO-END ANASTOMOSIS AND HYSTERECTOMY WERE PERFORMED.

  Patient problems: Bowel Burn; Burn(s); Uterine Perforation

  MAUDE report 21942523 ↗
• InjuryApr 21, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6)2025 THE TREATING PHYSICIAN PERFORMED AN ABLATION WITH MINERVA ES. PRIOR TO ABLATION, DIAGNOSTIC HYSTEROSCOPY WAS PERFORMED AND REVEALED A NARROW UTERINE CAVITY AND "FLUFFY" ENDOMETRIUM. MINERVA SURGICAL SALES REPRESENTATIVE WAS PRESENT DURING PROCEDURE AND SUGGESTED CONSIDERING THE USE OF THE GENESYS HTA SYSTEM. THE PHYSICIAN CONTINUED WITH MINERVA SYSTEM. THE MINERVA ES HANDPIECE WAS INSERTED AND DEPLOYED IN THE RED. THE TREATING PHYSICIAN TRIED TO MANIPULATE THE DEVICE TO MOVE IT INTO THE GREEN BUT WAS UNSUCCESSFUL AND THE DEVICE WAS REMOVED. DIAGNOSTIC HYSTEROSCOPY WAS REPEATED. THE MINERVA DEVICE WAS INSERTED AGAIN, DEPLOYED, AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2025, THE PATIENT REPORTED WITH LOWER ABDOMINAL PAIN, WENT TO THE ER AND WAS DIAGNOSED WITH A UTERINE PERFORATION AT THE FUNDUS AND THERMAL INJURY TO THE BOWEL. LAPAROSCOPIC BOWEL RESECTION WAS PERFORMED. AS OF (B)(6) 2025, THE PATIENT IS STABLE AND RECOVERING.

  Patient problems: Bowel Burn; Uterine Perforation

  MAUDE report 21876239 ↗
• InjuryMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TREATING PHYSICIAN HAD ORIGINALLY SOUNDED THE PATIENT TO A TOTAL LENGTH OF 5.5. DUE TO THE PATIENT HAVING AN ANTEVERTED UTERUS, THE PHYSICIAN DETERMINED THAT WAS INCORRECT AND RESOUNDED THE PATIENT TO A SOUND LENGTH OF 9. THE MINERVA HANDPIECE WAS INSERTED AND PERFORMED THE UTERINE INTEGRITY TEST (UIT) WHICH FAILED. THE PHYSICIAN USED A SCOPE AND IDENTIFIED A PERFORATION INSIDE THE UTERUS AT THE LEFT CORNU. THE PROCEDURE WAS THEN ABORTED AND NO ENERGY WAS DELIVERED TO THE PATIENT. THE DOCTOR SEALED THE PERFORATION LAPAROSCOPICALLY.

  Patient problems: Uterine Perforation

  MAUDE report 21560999 ↗
• InjuryMar 10, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED TO MINERVA SURGICAL THAT ON (B)(6) 2025, THE PHYSICIAN ATTEMPTED A MINERVA ENDOMETRIAL ABLATION. THE UTERINE INTEGRITY TEST (UIT) FAILED INDICATING A POSSIBLE UTERINE PERFORATION, WHICH WAS THEN CONFIRMED DURING DIAGNOSTIC HYSTEROSCOPY OXIDIZED REGENERATED CELLULOSE (ORC) WAS APPLIED LAPAROSCOPICALLY. THE PATIENT FULLY RECOVERED AND IS DOING WELL.

  Patient problems: Uterine Perforation

  MAUDE report 21559952 ↗
• InjuryOct 31, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED AN ENDOMETRIAL ABLATION PROCEDURE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WHERE THE PATIENT REPORTED SYMPTOMS INCLUDING PELVIC PAIN, NAUSEA, AND VOMITING. UTERINE PERFORATION AND THERMAL EFFECT ON THE BOWEL WAS CONFIRMED.

  Patient problems: Bowel Burn; Uterine Perforation

  MAUDE report 20581727 ↗
• InjuryOct 9, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED, THE PHYSICIAN PERFORMED AN UNEVENTFUL ENDOMETRIAL ABLATION PROCEDURE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WHERE AN ULTRASOUND WAS PERFORMED WHICH CONFIRMED THE PRESENCE OF A UTERINE PERFORATION AND THERMAL EFFECT ON THE BOWEL. PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN ILEOSTOMY.

  Patient problems: Bowel Burn

  MAUDE report 20409968 ↗
• InjuryJun 17, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED, A DIAGNOSTIC HYSTEROSCOPY, POST ABLATION, WAS PERFORMED SHOWING EVIDENCE OF A FUNDAL UTERINE PERFORATION, THE PATIENT WAS DISCHARGED SHORTLY AFTER. LATER THAT SAME DAY THE PATIENT BEGAN TO EXPERIENCE LOWER ABDOMINAL PAIN AND ON 5/29 THE PATIENT WENT TO THE EMERGENCY DEPARTMENT. LAPAROSCOPY WAS PERFORMED AND A UTERINE PERFORATION WAS CONFIRMED WITH AN AREA OF UNINTENDED THERMAL EFFECT ON THE BOWEL. A SMALL BOWEL RESECTION AND END TO END ANASTOMOSIS WAS PERFORMED.

  Patient problems: Bowel Burn; Uterine Perforation

  MAUDE report 19554878 ↗
• InjuryJun 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO RECEIVED A MINERVA ABLATION PROCEDURE, UNKNOWN PROCEDURE DATE, HAD A BOWEL BURN. THE PATIENT HAD A BOWEL RESECTION AND IS REPORTEDLY DOING WELL. THE PHYSICIAN DID NOT PROVIDE THE ORIGINAL PROCEDURE DATE, THE SURGICAL INTERVENTION DATE, OR ANY OTHER INFORMATION. THE PHYSICIAN REQUESTED NOT TO BE CONTACTED AND WOULD NOT PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Bowel Burn

  MAUDE report 19543881 ↗
• InjuryMay 17, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED, THE TREATING PHYSICIAN PERFORMED AN UNINTERRUPTED ABLATION CYCLE WITH THE MINERVA SYSTEM. DIAGNOSTIC HYSTEROSCOPY POST-ABLATION WAS PERFORMED SHOWING EVIDENCE OF TISSUE ABLATION AND THE PATIENT WAS DISCHARGED SHORTLY THEREAFTER. LATER THE SAME DAY, THE PATIENT STARTED EXPERIENCING LOWER ABDOMINAL PAIN AND ON (B)(6) 2024 REPORTED TO THE NEARBY EMERGENCY DEPARTMENT. AFTER EVALUATION IT WAS SUSPECTED THAT THE PATIENT SUFFERED A BOWEL INJURY. SURGICAL CONSULT WAS CALLED IN AND LAPAROTOMY WAS PERFORMED. AT THE TIME OF SURGERY ABSENCE OF A MECHANICAL UTERINE PERFORATION, WITH AN AREA AT THE FUNDUS EXHIBITED EVIDENCE OF BLANCHING WAS OBSERVED. UNINTENDED THERMAL EFFECT WAS PRESENT ON THE BOWEL, WHICH BY THE TIME OF LAPAROTOMY WAS ALREADY PERFORATED. SMALL BOWEL RESECTION AND END-TO-END ANASTOMOSIS WAS PERFORMED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Bowel Burn

  MAUDE report 19341407 ↗
• MalfunctionMay 7, 2024

  ERROR CODE 002 CAME UP WITH EIGHT SECONDS LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257792 ↗
• MalfunctionMay 6, 2024

  UTERINE INTEGRITY TEST FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247517 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ABOUT NINE MONTHS AGO, EXACT DATE UNKNOWN, THE TREATING PHYSICIAN PERFORMED A MINERVA ABLATION ON A PATIENT. THE PATIENT DEVELOPED POST ABLATION TUBAL STERILIZATION SYNDROME (PATSS). THE PHYSICIAN ATTEMPTED TO RECTIFY PATSS HYSTEROSCOPICALLY, HOWEVER WAS UNSUCCESSFUL. THE PATIENT HAD TO UNDERGO A SUPRACERVICAL HYSTERECTOMY.

  Patient problems: Pain

  MAUDE report 19226836 ↗
• InjuryApr 1, 2024Use of Device Problem; Use of Device Problem

  A LAPAROSCOPIC SALPINGECTOMY (PERFORMED BY AN OB/GYN RESIDENT) FOLLOWED BY A MINERVA ENDOMETRIAL ABLATION (PERFORMED BY ATTENDING PHYSICIAN) WERE PERFORMED IN A 37-YEAR-OLD PATIENT SUFFERING FROM AUB (E), WITH A HISTORY OF 2 CESAREAN DELIVERIES AND AN AUTO-IMMUNE DISEASE. LATER THE SAME DAY, THE PATIENT STARTED EXPERIENCING LOWER ABDOMINAL PAIN AND REPORTED TO THE NEARBY EMERGENCY DEPARTMENT OF A HOSPITAL OTHER THAN THE ONE WHERE THE ORIGINAL PROCEDURE WAS PERFORMED. A CT SCAN WAS PERFORMED AND DID NOT IDENTIFY ANY ABNORMALITIES. THE PATIENT ELECTED TO LEAVE THIS FACILITY AND CHOSE TO SEEK CARE AT THE HOSPITAL WHERE THE PROCEDURE WAS DONE AND WHERE SHE WORKS. SHE WAS EVALUATED AND WBC CAME BACK ELEVATED TO 22K. THE PATIENT WAS TAKEN TO THE OPERATING ROOM. DIAGNOSTIC LAPAROSCOPY REVEALED ABSENCE OF A MECHANICAL UTERINE PERFORATION, BUT AN AREA AT THE FUNDUS EXHIBITED EVIDENCE OF BLANCHING. A SIMILAR AREA OF THE ILEUM HAD EVIDENCE OF UNINTENDED THERMAL EFFECT. SMALL BOWEL RESECTION AND END-TO-END ANASTOMOSIS WAS PERFORMED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Bowel Burn

  MAUDE report 19011978 ↗
• InjuryMar 4, 2024Use of Device Problem; Use of Device Problem

  THE TREATING PHYSICIAN PERFORMED A MINERVA ENDOMETRIAL ABLATION IN A 35-YEAR-OLD PATIENT SUFFERING FROM AUB (E). PRIOR TO THAT THE PATIENT UNDERWENT ULTRASOUND IMAGING IN THE OFFICE AND NO INTRA-UTERINE PATHOLOGY WAS SEEN. ON THE DAY OF THE PROCEDURE DIAGNOSTIC HYSTEROSCOPY WAS PERFORMED. SUFFICIENT DISTENTION AND VISUALIZATION OF THE UTERINE CAVITY WAS ACHIEVED. NO EVIDENCE OF PATHOLOGY WAS PRESENT. THE UTERUS SOUNDED TO 9.5-CM, THE CERVIX WAS MEASURED USING THE HYSTEROSCOPE AND WAS 3.5-CM, AND THE CAVITY LENGTH WAS CALCULATED TO BE 6-CM. ABLATION PROCEDURE WAS REPORTED TO BE NOMINAL. POST-ABLATION HYSTEROSCOPY WAS PERFORMED AND DID NOT REVEAL ANY EVIDENCE OF UTERINE PERFORATION AND WAS NOT ASSOCIATED WITH ANY DISTENTION MEDIA LOSS. THE PATIENT WAS DISCHARGED SHORTLY THEREAFTER. THE FOLLOWING DAY THE PATIENT COMMUNICATED SOME LOWER ABDOMINAL PAIN AND 2 DAYS LATER REPORTED TO THE ER WITH ACUTE LOWER ABDOMINAL PAIN. AFTER EVALUATION THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND DIAGNOSED WITH TRANSMURAL THERMAL INJURY TO FUNDUS OF THE UTERUS WITHOUT A PHYSICAL/MECHANICAL PERFORATION AND A PERFORATED SIGMOID COLON, SECONDARY TO THERMAL EFFECT. THE PATIENT UNDERWENT BOWEL RESECTION

  Patient problems: Bowel Burn

  MAUDE report 18827968 ↗