MAUDE Adverse Event Report: CORDIS US. CORP BIOPSY FORCEP; DEVICE, BIOPSY, ENDOMYOCARDIAL

Model Number 504300

Device Problem Fracture (1260)

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

Event Date 05/08/2023

Event Type  malfunction  

Event Description

As reported, after opening a 5.5f 104cm standard biopsy forceps the device was found fractured into three parts.There was no reported injury to the patient and the device will be returned for evaluation.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after opening a 5.5f 104cm standard biopsy forceps the device was found fractured into three parts.Another 5.5f 104cm standard biopsy forceps was used to complete the procedure.There was no reported injury to the patient.The device was stored, handled, and prepped per the instructions for use (ifu).The device was not returned as expected.

Manufacturer Narrative

Complaint conclusion: after opening a 5.5f 104cm standard biopsy forceps the device was found fractured into three parts.Another 5.5f 104cm standard biopsy forceps was used to complete the procedure.The device was stored, handled, and prepped per the instructions for use (ifu).There was no reported injury to the patient.The device was not returned for analysis.A product history record (phr) review of lot 70322271 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿coiled shaft (biopsy forceps) ¿ fractured- separated was not confirmed.Handling factors or the user¿s interaction with the device during device preparation may have led to the reported event.According to the instructions for use ¿do not use if the inner package is open or damaged.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 70322271 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after opening a 5.5f 104cm standard biopsy forceps the device was found fractured into three parts.Another 5.5f 104cm standard biopsy forceps was used to complete the procedure.There was no reported injury to the patient.The device was stored, handled, and prepped per the instructions for use (ifu) and will be returned for evaluation.

• Brand Name: BIOPSY FORCEP
• Type of Device: DEVICE, BIOPSY, ENDOMYOCARDIAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 45 lexington drive; laconia, new hampshire 03246 ; 7863138372
• MDR Report Key: 17049553
• MDR Text Key: 316404268
• Report Number: 1016427-2023-05552
• Device Sequence Number: 1
• Product Code: DWZ
• UDI-Device Identifier: 10705032056090
• UDI-Public: (01)10705032056090(17)250228(10)70322271
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 504300
• Device Catalogue Number: 504300
• Device Lot Number: 70322271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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
• Patient Ethnicity: Hispanic