MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM

Model Number	701118060
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
3 devices fell apart.Doctor was stuck with the needle when it broke.
Event or Problem Description
3 devices fell apart.Doctor was stuck with the needle when it broke.
Additional Manufacturer Narrative
No sample or images were available for evaluation.However, due to this issue being reported numerous times for this part, the complaint was confirmed.Capa 21-001 was initiated to mitigate locking tab breakage on the supercore device.The design of part 3-01-01-196 locking tabs have been improved to require significant increase in pull force to remove the snap fit cap from the snap fit housing.The change was completed (b)(6) 2021.The affected lot was built with locking tabs manufactured prior to the implementation of the capa.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 18GA X 6CM
• Common Device Name: SUPERCORE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12269647
• Report Number: 0001625425-2021-01053
• Device Sequence Number: 14630944
• Product Code: KNW
• UDI-Device Identifier: 00886333005963
• UDI-Public: 00886333005963
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K974814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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 Model Number: 701118060
• Device Catalogue Number: 701118060
• Device Lot Number: 113710102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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