MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR ENSPIRE SYSTEM; BIOPSY INSTRUMENT

Model Number	E4115
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the serial number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 12/2099).
Event or Problem Description
It was reported that after the probe was positioned in the patient, the device activated on it's own and could not be stopped until it had finished the entire 6 samples.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the encor enspire breast biopsy system was received for service & repair.The encor enspire breast biopsy system was visually inspected upon receipt and was found to be poor condition as chips on both side panels, the tub, and the tray, the standby switch is scratched, the monitor has a gouge the left side bezel, a scratch on the right side bezel, and foam insulation exposed on the top front of the monitor, the silicone tubing /elbow adapter is discolored, cartridge filter is dirty, manufacturer serial number label is not the most current revision.Also, found that the e-box has a broken screw on the top right side where it mounts to the frame, upper ribbon cable on the rear of the e-box connected to port 1 of the edac board has bare wire showing in close proximity to the riser tube center section, riser tube ground wire connector is loose and twisted where it attaches to the center riser tube section, riser tube release pin is stuck, riser tube can be raised or lowered without pushing in the pin.The ground wire is interrupting the raising and lowering of the riser tube.The bushing for the rinse pivot is chipping, worn, and out of round.The vent and vacuum pivot bushings are worn.There are numerous nicks on the rinse pivot, causing it to interfere with the movement of the vent solenoid.The rinse, vent, and vacuum plunger tips show signs of saline residue.The urethane tubing from the vacuum pump exhaust outlet to the cartridge filter is discolored.The rinse plunger tip spring shows signs of corrosion on the yoke side of the spring.There are loose cable clips on the e-box.The device was functionally tested and failed the positioning test due to the riser tube not raising and lowering easily.No other anomalies were identified.Therefore, investigation is determined to be unconfirmed for reported that after the probe was positioned in the patient, the device activated on it's own and could not be stopped until it had finished the entire 6 samples.The root cause cannot be determined as the problem could not be reproduced.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 12/2099), g3.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : see h10.
Event or Problem Description
It was reported that after the probe was positioned in the patient, the device activated on it's own and could not be stopped until it had finished the entire 6 samples.There was no reported patient injury.

• Brand Name: ENCOR ENSPIRE SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12292487
• Report Number: 2020394-2021-01438
• Device Sequence Number: 4673169
• Product Code: KNW
• UDI-Device Identifier: 00801741086113
• UDI-Public: (01)00801741086113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E4115
• Device Catalogue Number: E4115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Weight: 84