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

Model Number G31576

Device Problems Fracture (1260); Difficult to Open or Close (2921); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

During an endoscopic procedure for biopsy sampling, the physician used a cook captura biopsy forceps without spike.It was reported that during the biopsy sampling, the forceps did not open correctly and broke at the base of the bit [jaws].It was also reported that it was impossible to remove the biopsy forceps from inside the patient.The physician had to stop the examination to be able to remove the biopsy forceps from gastroscope.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear plastic bag and an open pouch from the lot number provided in the report.The label matches the product returned.Five unused devices were also returned from the same lot number in the report.The photo attached is not the actual device, but shows the area that broke for reference.Our laboratory evaluation of the product said to be involved confirmed the report.A visual examination of the used device shows the cups to be opened on one side at a 90 degree angle and the other side to be closed.The link wires are bent and sticking out of the cup housing.During a functional test, this resulted in the forceps not opening/closing when the handle was manipulated.The device was not functionally tested down an endoscope due to the condition it was returned in.The used device and five unused devices were returned to the supplier and the following was provided: " there were 5 unused sealed devices and 1 used device in an open pouch.All the devices were visually evaluated.No defects to the handle, catheter, or cups' assembly were noted on the unused devices.The used device showed extensive damage to its drive wire on one side.The drive wire appeared to be cut on one side and hence couldn't transfer the force from the handle actuation to one side of the cups' assembly.The other side showed no such damage.The weld joint, cable and handle assembly showed no defects or damage.The devices were functionally evaluated.Upon initial evaluation, the complaint from the report is confirmed for the singular used device.During testing, with the used device held in straight, u-shape and three-loop coiled positions, respectively, the surgical forceps cup side with the drive wire intact opens and closes as intended despite the damage seen in the initial evaluation, however the side with the damaged drive wire does not meet with the other half as it is not being actuated.The weld joint, cable and handle assembly show no defects or damage.The root cause of the drive wire damage and the location where the cup assembly could have procured the damage is unknown.The unused devices were also functionally evaluated during testing, the devices were held in straight, u-shape and three-loop coiled positions, it was confirmed that the devices operated properly.The surgical forceps cups open and close as intended.The handle assemblies felt smooth while testing." the device history records were reviewed.There were no relevant defects mentioned in the device history record review checklist.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our laboratory evaluation of the product said to be involved confirmed the report.The link wire is disconnected from the drive wire.The supplier provided the following, "the root cause was not determined.No corrective action has been assigned.The complaint was confirmed.All devices receive a 100% inspection prior to release and shipment.It is believed that the defect occurred post shipment." the instructions for use (ifu) includes the following to ensure proper use of the device: "beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable.Open and close the cups to verify smooth handle operation and appropriate cup action.Become familiar with the amount of handle movement required to operate the cups.If any irregularities are noted, do not use.Note: exercising the handle while the forcep is coiled may result in damage to the performance characteristics of the forceps." "forceps cups must remain closed during introduction into, advancement through, and removal from endoscope.If cups are open, damage to forceps and/or endoscope may occur."gentle pressure must be used when operating handle of forceps.Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope." "with cups closed, insert forceps into accessory channel.Note: keep end of forceps extending from accessory channel straight at all times.Allowing forceps to hang from accessory channel may cause damage to forceps." "maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site." prior to distribution, all captura biopsy forceps without spike 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 BIOPSY FORCEPS WITHOUT SPIKE
• Type of Device: PTS ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 15042940
• MDR Text Key: 304720068
• Report Number: 1037905-2022-00395
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 00827002315761
• UDI-Public: (01)00827002315761(17)241112(10)W4536547
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G31576
• Device Catalogue Number: DBF-2.4-230-S
• Device Lot Number: W4536547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE - UNKNOWN MAKE OR MODEL