BERKELEY VC-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821925010475), received between Oct 22, 2021 and Jan 27, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 16, 2022Open, Classified

   Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving the use of collection canisters which were not designed for use with the VC-10, which can lead to serious injuries as it does not fit properly with the VC-10.

   Z-0078-2023 · Root cause: Labeling design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Unexpected Shutdown

  IT WAS REPORTED THE VC10 PUMP 115V HAD ITS MOTOR BLEW WHILE IN USE DURING DILATATION & CURETTAGE AND SUCTIONING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191514 ↗
• InjuryMar 5, 2024Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE APPROXIMATE BLOOD LOSS WAS 200 ML. THE BLEED WAS CONTROLLED PHARMACOLOGICALLY, WITH ERGONOVINE, TRANEXAMIC ACID, AND CARBOPROST ADMINISTERED FOR TREATMENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTIONS. THE PROCEDURE WAS COMPLETED, AND THE PATIENT REPORTEDLY IN STABLE CONDITION UPON DISCHARGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18842473 ↗
• InjuryFeb 14, 2024Decrease in Suction; Decrease in Suction

  ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS MUCH LONGER THAN ITS SCHEDULED TIME. IT WAS COMPLETED WITH LARGE AMOUNTS OF BLOOD LOSE. THE DEVICE WAS INSPECTED POST PROCEDURE. THE SUCTION WHICH SHOULD HAVE BEEN 71 CM HG WAS READING 62 CM HG OCCLUDED AT THE DEVICE INLET CONNECTOR. THE SUCTION IS BACK UP TO 68 CM HG. THE STAFF REFUSES TO USE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18708337 ↗
• InjuryDec 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTS SAFETY CONCERNS SURROUNDING THEIR VC-10 PUMP NOT FUNCTIONING PROPERLY WITH THE RED TUBING THEY RECEIVED DUE TO THE BACK ORDERS. THESE ISSUES RESULTED IN A PATIENT RETURNING TO THE HOSPITAL NEEDING A SECOND UNSPECIFIED SURGERY. THE FACILITY STATES THEY RECEIVED A LETTER FROM OLYMPUS STATING THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN UPDATED AND ¿DO NOT USE REPLACEMENT PARTS OR ACCESSORIES THAT ARE NOT COMPATIBLE WITH THE SYSTEM¿. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16004718 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS, TWO PATIENT EVENTS INVOLVING THE VC10 PUMP AND NON-OLYMPUS CANISTERS DUE TO THE OLYMPUS BERKELEY SAFETOUCH COLLECTION SYSTEM CANISTER BACK-ORDER. THE FACILITY USED A LARGER CANISTER WITH INADEQUATE SUCTION WITH TWO DIFFERENT PATIENTS. PATIENT ONE (1), REPORTED WITH PATIENT IDENTIFIER (B)(6), HAD A CESAREAN SECTION ON (B)(6) 2022 AND RETURNED TO THE FACILITY FIVE (5) WEEKS LATER ON (B)(6) 2022 WITH UNCONTROLLED BLEEDING FROM RETAINED PRODUCTS OF CONCEPTION. THE PATIENT HAD A DILATION AND CURETTAGE , A BLOOD TRANSFUSION, AND PERFORATION WHICH RESULTED IN A HYSTERECTOMY. THE PATIENT WAS ADMITTED TO THE ICU. PATIENT TWO (2), REPORTED WITH PATIENT IDENTIFIER (B)(6), HAD A MISCARRIAGE AND HAD A DILATION AND CURETTAGE ON (B)(6) 2022. SHE RETURNED TO THE EMERGENCY DEPARTMENT (B)(6) 2022 FOR HEAVY VAGINAL BLEEDING ASSOCIATED WITH RETAINED PRODUCTS OF CONCEPTION. THE PATIENT WAS REQUIRED TO HAVE A SECOND DILATION AND CURETTAGE PROCEDURE (B)(6) 2022 AND WAS SENT HOME ON MEDICATIONS TO KEEP HER UTERUS CONTRACTED TO PREVENT FUTURE BLEEDING. THE FACILITY REPORTED BOTH PATIENTS ARE RECOVERING. (B)(6) IS FOR PATIENT 1. (B)(6) IS FOR PATIENT 2. THIS IS REPORT 2 OF

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15175727 ↗
• InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS, TWO PATIENT EVENTS INVOLVING THE VC10 PUMP AND NON-OLYMPUS CANISTERS DUE TO THE OLYMPUS BERKELEY SAFETOUCH COLLECTION SYSTEM CANISTER BACK-ORDER. THE FACILITY USED A LARGER CANISTER WITH INADEQUATE SUCTION WITH TWO DIFFERENT PATIENTS. PATIENT ONE (1), REPORTED WITH PATIENT IDENTIFIER (B)(6), HAD A CESAREAN SECTION ON (B)(6) 2022 AND RETURNED TO THE FACILITY FIVE (5) WEEKS LATER ON (B)(6) 2022 WITH UNCONTROLLED BLEEDING FROM RETAINED PRODUCTS OF CONCEPTION. THE PATIENT HAD A DILATION AND CURETTAGE , A BLOOD TRANSFUSION, AND PERFORATION WHICH RESULTED IN A HYSTERECTOMY. THE PATIENT WAS ADMITTED TO THE ICU. PATIENT TWO (2), REPORTED WITH PATIENT IDENTIFIER (B)(6), HAD A MISCARRIAGE AND HAD A DILATION AND CURETTAGE ON (B)(6) 2022. SHE RETURNED TO THE EMERGENCY DEPARTMENT (B)(6) 2022 FOR HEAVY VAGINAL BLEEDING ASSOCIATED WITH RETAINED PRODUCTS OF CONCEPTION. THE PATIENT WAS REQUIRED TO HAVE A SECOND DILATION AND CURETTAGE PROCEDURE (B)(6) 2022 AND WAS SENT HOME ON MEDICATIONS TO KEEP HER UTERUS CONTRACTED TO PREVENT FUTURE BLEEDING. THE FACILITY REPORTED BOTH PATIENTS ARE RECOVERING. (B)(6) IS FOR PATIENT 1, (B)(6) IS FOR PATIENT 2. THIS IS REPORT 1 OF

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Uterine Perforation

  MAUDE report 15175717 ↗
• MalfunctionMar 10, 2022Suction Problem; Suction Problem

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC DILATATION AND CURETTAGE WITH SUCTION PROCEDURE FOR A PREGNANCY AT 10 WEEKS, THE SUBJECT DEVICE SUCTIONED MORE THAN IT SHOULD HAVE DURING THE PROCEDURE AND THE PATIENT HAD A BLOOD LOSS OF 500 MLS. THE PHYSICIAN TURNED ON THE SUCTION AND HEARD 3 LOUD SOUNDS. THE CUSTOMER STATED THE NOISE COULD HAVE BEEN CANISTERS RATTLING IN THE MACHINE BECAUSE THEY ARE SMALLER. THE PHYSICIAN NOTED THE BLEEDING OCCURRED TOWARD THE BEGINNING OF THE PROCEDURE AFTER THE FIRST SHARP CURETTING. NO INTERVENTION OR TREATMENT WAS PROVIDED DUE TO THE BLOOD LOSS AND THE PATIENT WAS DISCHARGED. THE PATIENT'S PRE-OPERATIVE AND POST-OPERATIVE BLOOD PRESSURE RANGED 119/73- 121/76. THE PATIENTS PRE-OPERATIVE HEMOGLOBIN WAS 12.5 AND HEMATOCRIT WAS 39.6. NO POST-OPERATIVE LABS WERE TAKEN. THE PATIENT DID NOT EXPERIENCE SIGNS AND SYMPTOMS OF BLOOD LOSS POST-OPERATIVELY AND DID NOT RECEIVED A BLOOD TRANSFUSION POST-OPERATIVELY. THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND IT APPEARED TO BE IN WORKING ORDER PER THE CUSTOMER. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO DELAY IN THE PROCEDURE. THE CUSTOMER STATED THEY WERE UNABLE TO

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13723810 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: THE SOURCE OF BLEEDING WAS TWO CERVICAL LACERATIONS DUE TO THE DIFFICULTY WITH DILATION. THE BLEEDING WAS TREATED WITH SUTURES AND ADMINISTRATION OF METHERGINE X1. THE PATIENT'S CURRENT CONDITION IS STABLE, DISCHARGED WITH NO FURTHER BLEEDING. THE VC-10 DID NOT CAUSE OR CONTRIBUTE TO THE PROLONGATION OF THE PROCEDURE OR BLEEDING, THIS WAS CAUSED BY ANATOMICAL COMPLICATIONS AND LACK OF PREP. THE SERIAL NUMBER OF THE VC-10 CANNOT BE PROVIDED. THE VC-10 DID NOT MALFUNCTION IN ANY WAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12679112 ↗