MAUDE Adverse Event Report: COOK, INC. CAPTURA® BIOPSY FORCEPS; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number G56133

Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Event Description

The cook biopsy forceps were able to close, but unable to retract into endoscope.Endoscope had to be removed with biopsy forceps extended beyond tip of scope.Once removed, the team noted that the sheath of the biopsy forcep was rolled back, which prevented it from being pulled back into the endoscope.We were able to adjust the sheath manually in order to remove it from the endoscope.Once again, the patient was intubated with the same endoscope after testing a new biopsy forcep.The procedure was completed safely and without incident.This biopsy forcep was saved for further evaluation.Suggestion: careful inspection of the biopsy forcep sheath upon opening package, although this may still occur.Endoscopically carefully view the forceps and test that they open well prior to insertion into biopsy channel of scope.Manufacturer response for cook biopsy forceps, captura serrated forceps with spike (per site reporter).The district manager from cook, (b)(4), has the device.

• Brand Name: CAPTURA® BIOPSY FORCEPS
• Type of Device: FORCEPS, BIOPSY, NON-ELECTRIC
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6604099
• MDR Text Key: 76395593
• Report Number: 6604099
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/06/2020
• Device Model Number: G56133
• Device Catalogue Number: DBF-2.4SN-230SP-40-S
• Device Lot Number: W3814950
• Other Device ID Number: 230SP-40-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE
• Patient Age: 11 YR