MAUDE Adverse Event Report: MEDGYN PRODUCTS, INC. BIERER OVUM FORCEPS; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Problems Entrapment of Device (1212); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

Findings: 7 laminaria removed; midline 19 week uterus, products of conception consistent with 19 week pregnancy, all fetal parts accounted for.Complications: instrument problems with bierer forceps.Mirena lot #: tu011df indications for procedure: this is a gravida 4, para 3 at 19-1/2 weeks who had an undesired pregnancy.She was counseled on her options and elected to proceed with a termination procedure.She had previously had 7 laminaria placed for cervical dilation and presented to the operating room.Description of procedure: the patient was placed in dorsal lithotomy position.She had a general anesthetic placed without complication.She was prepped and draped in the usual surgical fashion.The laminaria had previously been removed prior to prepping.Surgical pause was taken in according with who protocol.She received 200 mg of iv doxycycline for perioperative prophylaxis and had pneumoboots placed for deep vein thrombosis (dvt) prophylaxis.The cervix was inspected and found to be about 1 to 2 cm dilated.It was tested and the bierer ovum forceps were able to pass easily.A 16 mm cannula was placed and attached to a vacuum suction.The amniotic sac was broken, umbilical cord was broken and all amniotic fluid evacuated.Following that, the bierer ovum forceps were used to extract the fetus under ultrasound guidance.At one point in the procedure it was noted that the bierer forceps had malfunctioned and jammed on some tissue.This was removed carefully and without any trauma to the surrounding tissues.The procedure was then completed.The vacuum suction was used to evacuate all remaining products of conception and all fetal parts were accounted for.At the end of the procedure, a thin endometrial stripe was visible on ultrasound and hemostasis was adequate and the uterus had a gritty texture.All instruments were removed.All sponge counts were correct.
=
manufacturer response for bierer ovum, brerer ovum forceps (per site reporter).
=
the quality and safety department has requested that this product be made available if the company representative wants to inspect the product.This failure occurred during an or procedure, but did not result in harm to the patient.

• Brand Name: BIERER OVUM FORCEPS
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): MEDGYN PRODUCTS, INC.; 100 w. insdustrial road; addison IL 60101
• MDR Report Key: 4891509
• MDR Text Key: 6828919
• Report Number: 4891509
• Device Sequence Number: 1
• Product Code: KOH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2015
• Patient Sequence Number: 1
• Patient Age: 34 YR