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

Model Number M0065051600

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: device code a020503 captures the reportable event of packaging caused forcep to spring out causing contamination.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 317658288
• Report Number: 3005099803-2023-02949
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 08714729302599
• UDI-Public: 08714729302599
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0065051600
• Device Catalogue Number: 505-160
• Device Lot Number: 0029815280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1