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

Model Number	G47693
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual evaluation was performed, however a functional evaluation was not done due to the condition of the returned device.The device was returned with the cup housing detached from the coiled catheter.There were also two link wires which had broken off.These two link wires detached from the forceps cup housing during evaluation.The weld marks on the outside of the fork arms are present, but do not appear to be centered.The weld mark on the inside of one of the fork arms is not present.There is also only one weld mark that is visible on the coiled catheter.The distal end of the coiled catheter has some slight damage.The device will be sent to the supplier for further evaluation.The supplier provided the following: "the forceps were visually evaluated.The tip was no longer attached to the coil cable and the wires have been cut.There was no visible damage to the tip or wires.There was evidence that the tip was previously attached to the coil cable.When examining the tip forks, it was noted that the weld spots are out of location.The weld spot did not meet specification.A functional evaluation is not possible; the tip is no longer attached to the coil cable.The device cannot function in this condition.The customer complaint of "the jaw clamp came off" was confirmed.The tip was no longer attached to the coil cable.The welds were not in proper location.The device history records for were reviewed.The assembly order was manufactured in may 2019.There were no relevant defects noted in the manufacturing and/or final quality control checklist records." investigation conclusion: the supplier provided the following: the user's complaint that the "forceps broke" was confirmed.The assignable cause was an improper location of the weld spots.A corrective action has been issued to address weld issues associated with these devices.Prior to distribution, all captura pro 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: the forceps supplier has initiated a corrective action in an effort to reduce occurrences of this nature.A review of the complaint history was conducted.The likelihood of occurrence is considered remote.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook captura pro¿ biopsy forceps with spike.The forceps were advanced down through the endoscope and when the staff personnel went to open the forceps, they broke.The jaw clamp [forceps cups] came off.Another forceps was used to retrieve jaw clamps.No harm to the patient.They used another forceps to complete the procedure.The device was evaluated and the entire cups housing and two link wires were returned detached from the coil catheter.A section of the device did not remain inside the patient¿s body.The detached portion of the forceps was retrieved with another forceps due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: CAPTURA PRO¿ BIOPSY FORCEPS WITH 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: 8866788
• Report Number: 1037905-2019-00449
• Device Sequence Number: 2514200
• Product Code: PTS
• UDI-Device Identifier: 00827002476936
• UDI-Public: (01)00827002476936(17)220514(10)W4215282
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: G47693
• Device Catalogue Number: BF-2.2S-230SP-40
• Device Lot Number: W4215282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention