MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PIRANHA; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M0065051600
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a020503 captures the reportable event of packaging caused forcep to spring out causing contamination.
Event or Problem Description
It was reported to boston scientific corporation that a piranha forceps was to be used in a prostate biopsy procedure on (b)(6) 2023.During the unpacking, as per the customer's feedback, the forceps became contaminated due to the packaging causing it to spring out.No patients were involved in this event.
Event or Problem Description
It was reported to boston scientific corporation that a piranha forceps was to be used in a prostate biopsy procedure on (b)(6) 2023.During the unpacking, as per the customer's feedback, the forceps became contaminated due to the packaging causing it to spring out.No patients were involved in this event.
Additional Manufacturer Narrative
Device code (b)(4) captures the reportable event of packaging caused forcep to spring out causing contamination the returned piranha forceps was analyzed, and a visual inspection observed that the device was returned in a partially opened pouch, which supports the reported complaint.The pouch had evidence of being previously sealed, but the device itself did not show any physical damage.The reported event was confirmed.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.Based on all available information, the device analysis, along with a review of the product record, confirms that the device adheres to manufacturing specifications, successfully passing all inspections and controls.No assembly issues were noted.Additionally, the analysis showed that the returned pouch had been partially opened, suggesting it was once sealed.Therefore, the most probable root cause is cause not established.

• Brand Name: PIRANHA
• Common Device Name: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17066397
• Report Number: 3005099803-2023-02949
• Device Sequence Number: 17665943
• Product Code: FCL
• UDI-Device Identifier: 08714729302599
• UDI-Public: 08714729302599
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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 Expiration Date: 07/21/2025
• Device Model Number: M0065051600
• Device Catalogue Number: 505-160
• Device Lot Number: 0029815280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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
• Patient Sex: Unknown