MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC MAMMOTOME REVOLVE STEREOTACTIC PROBE; BIOPSY SYSTEM,

Catalog Number	4010-02-15-T4
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate that during a patient having a breast clips, we used a t4 lot f12147319d, but could see this was not correct and looked to be the same as the t3 placed - lot f12147317d.The patient was ok and no further clips were placed.We have removed all stock of this t4 so have x19 to return and be replaced.
Additional Manufacturer Narrative
The hydromark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The instruction for use and deployment guide, provided with the device, must be followed to avoid the applicator from shearing.In accordance with iso 13485:2016 and iso 10993-1 requirements, the mammomark¿ biopsy site identifier devices have been tested for biocompatibility for their intended use and patient contact duration per iso 10993-1.The collagen marker and titanium clip are the only mammomark components classified as having "permanent patient contact." components of the applicator are classified as "limited patient contact" and qualified for the intended use during the procedure.Applicator materials are considered medical-grade but have not been evaluated for permanent implantation.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.It was reported that there was a labeling issue, a t4 was labeled as a t3.There was no harm to the patient and no further clips were placed.The customer returned 19 devices and all were investigated.All were found to be correct and no labeling issues were found.We have informed production line of the event and no issues have been found.There have been no similar complaints that have come in from the field.  if new information comes available the incident will be reassessed accordingly.   .

• Brand Name: MAMMOTOME REVOLVE STEREOTACTIC PROBE
• Common Device Name: BIOPSY SYSTEM,
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e business way; unit 500; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial,, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian rodriguez ; 300 e business way; unit 500; cincinnati, OH 45241
• MDR Report Key: 14526757
• Report Number: 3008492462-2022-00008
• Device Sequence Number: 5799176
• Product Code: KNW
• UDI-Device Identifier: 10841911102165
• UDI-Public: (01)10841911102165(17)221108(10)F12147319D
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/08/2022
• Device Catalogue Number: 4010-02-15-T4
• Device Lot Number: F12147319D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown