MAUDE Adverse Event Report: INVIVO CORPORATION FULLY AUTOMATIC BIOPSY GUN 18G 150MM

Model Number	989603202983
Medical Device Problem Codes	Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	06/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Today (b)(6) 2020), a mri prostate biopsy had an adverse event in which the needle did not retract properly, resulting in the biopsy needle entering the bladder.
Additional Manufacturer Narrative
A report was received on 12june2020 indicating that during a mri prostate biopsy the fully automatic biopsy needle (fabg) did not retract properly.This resulted in the fabg 18g, 150mm; mri needle entering the patient¿s bladder.The fabg was retrieved and sent to the contract manufacture for a thorough investigation.The investigation revealed that the returned device was fully functional and passed all visual and functional testing.However, the described product behavior by the customer is most likely attributed to use of the device problem when pushing the locking lever midway towards the fire setting instead of all way toward the fire setting, in that case the gun will only shoot out the inner needle and not the outer cannula.
Event or Problem Description
A report was received on 12june2020 indicating that during a mri prostate biopsy the fully automatic biopsy needle (fabg) did not retract properly.This resulted in the fabg 18g 150mmmri needle entering the patients bladder.
Event or Problem Description
On (b)(6) 2020 complaint with pr# (b)(6) was received concerning a fabg failure to retract while conducting a prostate biopsy, this alleged failure caused the needle to puncture the patient¿s bladder resulting in hematuria.Per follow-up with event reporter no hospitalization nor medical treatment was required, and no complications were reported.Alleged defective product was returned to philips for investigation, philips shipped product to contract manufacturer for testing; testing results received on 31-aug-2020 show no product malfunction and passed all functional tests required.This hhe was created to re-evaluate the risk after this reported injury.Based on the investigation there is no indication that product failure is present with the products distributed since there are no other injuries reported.Based on the investigation performed on the retuned device and collected information as part of the complaint investigation there is enough data to conclude that this injury in an isolated event.

• Brand Name: FULLY AUTOMATIC BIOPSY GUN 18G 150MM
• Common Device Name: FULLY AUTOMATIC BIOPSY GUN 18G 150MM
• Manufacturer (Section D): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer (Section G): INVIVO CORPORATION; 3545 sw 47th ave; gainesville FL 32608
• Manufacturer Contact: kenneth revennaugh ; 3545 sw 47th ave; gainesville, FL 32608
• MDR Report Key: 10192567
• Report Number: 1056069-2020-01000
• Device Sequence Number: 3016478
• Product Code: KNW
• UDI-Device Identifier: 00884838072541
• UDI-Public: 00884838072541
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K010037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2024
• Device Model Number: 989603202983
• Device Catalogue Number: 989603202983
• Device Lot Number: 11776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/12/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/12/2020; 06/12/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 09/30/2020; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male