MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC HEMOSPRAY ENDOSCOPIC HEMOSTAT; HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE

Model Number	G21049
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued: section g: 510k: k200972.Investigation evaluation: the product said to be involved was returned in a clear plastic bag.A lot number was not provided with the returned device.Photos provided show the broken red activation knob with the co2 cartridge resting inside of it laid next to the device handle within a clear plastic bag.Our laboratory evaluation of the product said to be involved confirmed the report.Not all components were included in the return, the foam, the regulator's small metal ball bearing, lance, spring, and black o-ring were not returned.Neither of the catheters were included in the return.The co2 cartridge and red activation know were moving freely within the clear plastic bag.The device was returned with the on/off switch in the "off" position.The white body of the handle has not broken open.A brown substance was noted on the exterior of the handle.Powder was not observed on the exterior of the returned components, within the device nozzle, or within the plastic bag.The red activation knob was returned removed from the handle with a detached portion remaining seated around the regulator in the handle.No portion of the activation knob appears to be missing.The activation knob is marked as being formed with core pin #1.The regulator's internal components have detached with only the small white o-ring remaining seated in the regulator.The co2 cartridge was observed to be fully punctured.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product prior to distribution.However, this product lot# is within the scope of the recall.Investigation conclusion: our laboratory evaluation of the product said to be involved confirmed the report.The activation knob has cracked around the threaded area where it was secured to the regulator during activation.A field action (reference field action 066-r and 067-r) has been initiated for this nonconformance; the reported lot: w4855699, is within the scope of this action.A supplier corrective action request (scar) was initiated to further investigate device failure due activation knob breakage.This device is within the scope of the scar.Prior to distribution, all hemospray endoscopic hemostats 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.A supplier corrective action request (scar) was initiated to further investigate device failure due activation knob breakage.This product is included in the scope of this supplier corrective action request.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
In preparation for an endoscopic procedure to treat an egd bleed, the physician selected a cook hemospray endoscopic hemostat.It was reported that while twisting the activation knob, the co2 [carbon dioxide] exploded and the handle shot off and hit the doctor in the belly.The doctor did not require medical attention for this.They successfully completed the procedure with a different device of some type.A section of the device did not remain inside the patient¿s body.The patient or user 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.

• Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
• Common Device Name: HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE
• 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: 20522850
• Report Number: 1037905-2024-00656
• Device Sequence Number: 9105018
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)270722(10)W4855699
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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 Model Number: G21049
• Device Catalogue Number: HEMO-10
• Device Lot Number: W4855699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 95300
• Patient Sequence Number: 1
• Patient Sex: Unknown