Summary of MedSun Reports Describing Adverse Events with the Cooper Surgical M-Style Mushroom Cup Vacuum Assisted Delivery System
MedSun: Newsletter #33, February 2009

Over the past 10 months, MedSun has received 5 adverse event reports associated with the M-Style Vacuum Assisted Delivery System, which includes the Mushroom Cup, and the M-Style Cup, which is manufactured by Cooper Surgical. The reports were submitted by 4 hospitals between 2007 and October 2008. The two main reported device problems were:

•Three reports of the physician unable to release the suction cup from the infants head after application of suction. Manual release of the suction cup was needed in these cases.
•Two reports of the suction cup popping off during the procedure.

The patient injuries are listed below:

•Two reports mentioned small marks left on the infants head
•Another report mentioned a 4th degree perineal laceration experienced by the maternal patient, and lower APGAR scores of the delivered infant due to the longer delivery time.

Although not listed in these reports, hematoma injuries, either cephalohematoma or subgaleal, are potential rare complications associated with vacuum-assisted vaginal deliveries.

These MedSun reports contributed to FDA awareness of the device problems. FDA follow-up with the manufacturer resulted in a Class II Recall of the device.

On September 17, 2008, the M-Style Mushroom Cup Vacuum Assisted Delivery System was voluntarily recalled by Cooper Surgical because the Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby. Included is a link which addresses the problem and lists the products which are covered.

The two recall numbers are: Z-1887-2008, and Z1888-2008.






MedSun Newsletters are available at www.fda.gov/cdrh/medsun
Cooper Surgical M-Style Vacuum Assisted Delivery System
Device Device Identifiers Event Description
Cooper Surgical/M-Style Mushroom Cup Vacuum Assisted Delivery System Ref # 10007LP Lot # 60734 After vacuum delivery, the cup did not easily release from infants head after pressure was released. Cup removed manually by physician. Small vacuum mark noted to infants head.
Cooper Surgical/M-Style Vacuum Assisted Delivery System Ref # 10007LP
Lot # 65910
Physician placed the M-Style Mityvac at 10 mm Hg then pumped it up to 50 mm Hg one minute later. The physician pulled for 20 seconds until delivery. Once delivered, the vacuum was released, but the doctor was unable to remove the suction device from the baby's head for approximately one minute. Finally, the doctor had to place their finger under vacuum head to release the suction. Small marks noted on the head of the baby. After a few hours, the marks were no longer visible, and the baby was discharged home with no further complications.
Cooper Surgical/M-Style Vacuum Assisted Delivery System Catalog # 10007LP After obtaining consent for a vacuum delivery, the mushroom cup Mityvac was placed and position was checked. Over the next two contractions, the physician did attempt to pull with the vacuum and there was one pop-off. The vacuum was not maintaining adequate suction beyond a level of 10-15. The vacuum was removed and a new replacement pump was obtained as well as the vacuum cup and tubing. The new vacuum was placed and again position was checked. Steady progress was made and the vacuum was maintained at approximately 45-50 in the green zone and there were no pop-offs. The cup and tubing was not retained and the lot number was not recorded. Early this year, a recall notice was received from Cooper Surgical regarding a recall of specific lot numbers of the disposable vacuum assisted delivery products. We did pull from inventory 12 items from one affected lot number.
Cooper Surgical/Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System Model # 10057 Mityvac was used to assist with delivery in appropriate range (40-50cmHg) and traction was applied through one contraction. With the second contraction, the cap disengaged from the rest of the vacuum and maintained suction on the fetal head.

After the failure of the vacuum extraction device, forceps were needed for the delivery, and there was a maternal perineal 4th degree laceration as a result. To remove the attached extraction cap from the infant's head, the physician had to insert her finger under the cap and slide it fully around the cap edge.

No additional intervention was required for the infant, but there were lower APGAR scores due to the longer delivery time.

It is believed that the device was defective, especially due to the fact that the cap did not release easily, and the doctor stated that the vacuum applied was in the green range. Undue force was not applied.
Cooper Surgical/Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System Model # 10057
Lot # 57913
Upon SVE (Sterile Vaginal Examination) patient complete and prepared for delivery. MD applied vacuum and vacuum popped off; re-applied, and while the MD was pulling during birth, the vacuum broke. A new vacuum was applied and another pop-off occurred. MD allowed patient to push without vacuum, and vacuum re-applied; vacuum disengaged.