MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA BIOPSY FORCEPS WITH SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number G56074

Device Problems Peeled/Delaminated (1454); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual inspection of the device showed multiple areas along the full length of the device where the sheath was cracked or missing pieces.At 1 cm to 1.7 cm, 37.5 cm to 42.4 cm, 92.2 cm to 97.4 cm, 144 cm to 160.5 cm, 203 cm to 219.4 cm measured from the base of the handle; the sheath was cracked and missing some pieces.The largest piece was detached from the device and returned inside the pouch with the forceps.It is unknown if this is the piece that was retrieved from the patient.The user indicated the event date was in (b)(6) 2019.This product lot expired in august 2015.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: it was observed that the product was used after the expiration date.Use of the product after the stated expiration date could cause the product to underperform.This is the most likely cause for the reported observation.Prior to distribution, all captura biopsy forceps with spike are subjected to a visual inspection 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 and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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.Additional comments regarding this report: based on the information provided that the device was used beyond its expiration date, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopy, the physician used a cook captura biopsy forceps with spike.The sheath came apart [flaked off] while it was being put down the endoscope.A new device was opened and used to complete the procedure.Clarification was received 07-mar-2019 stating that it was part of the gray sheath on the biopsy forceps that flaked off.The piece was retrieved with the biopsy forceps.The device was received for evaluation and the sheath was found to be cracked and missing some pieces.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 BIOPSY FORCEPS WITH SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• 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: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 8434237
• MDR Text Key: 142672904
• Report Number: 1037905-2019-00136
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002560741
• UDI-Public: (01)00827002560741(17)150813(10)W3182093
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2015
• Device Model Number: G56074
• Device Catalogue Number: DBF-2.4-230SP-20-S
• Device Lot Number: W3182093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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