MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA PRO BIOPSY FORCEPS WITHOUT SPIKE; PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT

Model Number	G47691
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently in progress.A follow-up emdr will be provided with the product evaluation information.
Event or Problem Description
During a colonoscopy procedure, the physician used a cook captura pro biopsy forceps without spike.One side of the cups would not move, but the other did.Also, they could not close the cups correctly.The device took one bite but they could not close the device after that.They were able to retrieve it manually but not as intended.The customer performed a hot biopsy to complete the procedure.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.
Additional Manufacturer Narrative
An emdr report was initially sent on 04/15/2021, based on the information that "during a colonoscopy procedure, the physician used a cook captura pro biopsy forceps without spike.One side of the cups would not move, but the other did.Also, they could not close the cups correctly.The device took one bite but they could not close the device after that.They were able to retrieve it manually but not as intended.The customer performed a hot biopsy to complete the procedure." additional information was received that stated "the forceps closed enough to be removed from the endoscope." based on the additional information, this incident no longer meets the reporting criteria of an fda mdr report.
Event or Problem Description
This correction follow up report is being submitted to cancel the initial report submitted relating to this event.Reference the additional information section for this justification.

• Brand Name: CAPTURA PRO BIOPSY FORCEPS WITHOUT SPIKE
• Common Device Name: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11673385
• Report Number: 1037905-2021-00154
• Device Sequence Number: 19580089
• Product Code: PTS
• UDI-Device Identifier: 00827002476912
• UDI-Public: (01)00827002476912(17)231222(10)W4419746
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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: 12/22/2023
• Device Model Number: G47691
• Device Catalogue Number: BF-2.2S-230-40
• Device Lot Number: W4419746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTAX COLONOSCOPE, UNKNOWN MODEL
• Patient Age: 68 YR
• Patient Weight: 93