MAUDE Adverse Event Report: COOK ENDOSCOPY CAPTURA HOT BIOPSY FORCEPS; KGE, FORCEPS, BIOPSY, ELECTRIC

Model Number	G31583
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the approved supplier for evaluation.A follow up emdr will be submitted upon receipt of the supplier investigation.
Event or Problem Description
During an endoscopic biopsy procedure, the physician used a cook captura hot biopsy forceps.The user opened the package and advanced the device through endoscope to desired position.The cups were "obviously deviated" [cups misaligned].The user retracted the device from patient.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 19-nov-2020, based on the information that the forceps cups were misaligned.The device was sent back to the supplier for further evaluation.The supplier evaluation was received and misalignment of the cups was not confirmed.The cup alignment was within specification.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 manufacturer narrative - notes section for this justification.

• Brand Name: CAPTURA HOT BIOPSY FORCEPS
• Common Device Name: KGE, FORCEPS, BIOPSY, ELECTRIC
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 10869541
• Report Number: 1037905-2020-00497
• Device Sequence Number: 11421862
• Product Code: KGE
• UDI-Device Identifier: 00827002315839
• UDI-Public: (01)00827002315839(17)221204(10)W4294327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K171973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 12/04/2022
• Device Model Number: G31583
• Device Catalogue Number: HDBF-2.4-230-S
• Device Lot Number: W4294327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/14/2020
• 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: OLYMPUS GIF H290 ENDOSCOPE
• Patient Age: 56 YR