MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE; EOQ BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	G47742
Medical Device Problem Codes	Solder Joint Fracture (2324); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with damage to the coating and the sheath.The cups were detached from the sheath and not returned.The coiled catheter had been stretched out and part of the wire is unraveling.A portion of the sheath has been pulled back and is exposing.5 cm of the coiled catheter.A review of the drive wire identified the solder joint between the drive wire and link wires is broken.The broken solder joint would result in the cups being unable to close.The remaining sheath portion of the device was measured and determined that at most a 6 cm of the device was not returned.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: due to the condition of the returned device, a complete evaluation was not possible.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Prior to distribution, all captura bronch biopsy forceps no spike are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During a bronchostomy, the physician used a cook captura bronch biopsy forceps no spike.It was reported that the forceps lodged in the scope.When the scope was pulled out, the sheath was damaged and unable to be pulled out from the scope.There was no reportable information at this time.The device was returned on (b)(6) 2021.The forceps was returned without the cups.There was damage to the distal end of the sheath.A review of the drive wire identified the solder joint between the drive wire and link wires is broken.The broken solder joint would result in the cups being unable to close.[subject of report] a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE
• Common Device Name: EOQ BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12860717
• Report Number: 1037905-2021-00652
• Device Sequence Number: 4608999
• Product Code: EOQ
• UDI-Device Identifier: 00827002477421
• UDI-Public: (01)00827002477421(17)240602(10)W4477418
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K163377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: 06/02/2024
• Device Model Number: G47742
• Device Catalogue Number: DBF-1.8-S
• Device Lot Number: W4477418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE - UNKNOWN MAKE OR MODEL.
• Patient Sex: Unknown