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

Model Number G50696

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided.

Event Description

In preparation for an endoscopic procedure, the physician selected a cook captura pro¿ biopsy forceps with spike.The jaws [cups] were not lining up properly.This was noted as the forceps were removed from their package and tested.This occurred prior to patient contact; there was no impact to the patient.

Event Description

In preparation for an endoscopic procedure, the physician selected a cook captura pro¿ biopsy forceps with spike.The jaws [cups] were not lining up properly.This was noted as the forceps were removed from their package and tested.This occurred prior to patient contact; there was no impact to the patient.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was not returned.The customer returned one (1) sealed device from the same lot in the report.The device was returned to the supplier for further evaluation.The supplier provided the following: visual evaluation: visually, no defects to the handle, catheter, or cups' assembly were noted.The reported event of "jaws not aligned" was not confirmed.Functional evaluation: during testing, with the devices held in straight, u-shaped, and three (3), 8 inch loop coiled positions, respectively, it was confirmed that the devices operated properly when the handle was manipulated.The device opened and closed as designed.The device history records were reviewed and were manufactured september 2019.There were relevant defects noted in the manufacturing and/or final quality control checklist records.The device goes through various inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the prior to use product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.For the returned unused device, the supplier did not confirm the complaint; the returned unused device functioned as intended.Prior to distribution, all captura pro¿ biopsy forceps 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 currently being assessed and a follow up report will be sent.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was not returned.The customer returned one (1) sealed device from the same lot in the report.The device was returned to the supplier for further evaluation.The supplier provided the following: visual evaluation: visually, no defects to the handle, catheter, or cups' assembly were noted.The reported event of "jaws not aligned" was not confirmed.Functional evaluation: during testing, with the devices held in straight, u-shaped, and three (3), 8 inch loop coiled positions, respectively, it was confirmed that the devices operated properly when the handle was manipulated.The device opened and closed as designed.The device history records were reviewed and were manufactured september 2019.There were relevant defects noted in the manufacturing and/or final quality control checklist records.The device goes through various inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the prior to use product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.For the returned unused device, the supplier did not confirm the complaint; the returned unused device functioned as intended.Prior to distribution, all captura pro¿ biopsy forceps 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.

• Brand Name: CAPTURA PRO 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
• MDR Report Key: 10493381
• MDR Text Key: 234272253
• Report Number: 1037905-2020-00361
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002506961
• UDI-Public: (01)00827002506961(17)220911(10)W4260385
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Model Number: G50696
• Device Catalogue Number: BF-2.4SL-230SP-20
• Device Lot Number: W4260385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1