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	Gastrointestinal Hemorrhage (4476)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an upper endoscopic procedure to treat an upper gi visceral bleed, the physician used a cook hemospray endoscopic hemostat.It was reported when activating and turning the knob, the medical staff heard a loud pop and the co2 gas escaped.The catheter had contacted the endoscope.The district manager confirmed with the end user that the device did not explode, only the gas escaped.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
Continued: section g: 510k: k200972.Investigation evaluation: the product said to be involved was returned in a clear biohazard bag.Provided with the return was a lid stock from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.Not all components were included in the return, the foam and black o-ring were not returned.Only one catheter was included in the return.The returned catheter has a red substance within the distal end, but no evidence of powder was observed within the clear tubing.The co2 cartridge and red activation knob were returned reinserted into the handle.The device was returned with the on/off switch in the "off" position.The white body of the handle was intact.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 removed from the handle and a detached portion remained 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 #2.The regulator remains intact with the lance remaining seated and was noted to be beveled.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 field action recall res95300.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 supplier corrective action request (scar) was initiated to further investigate device failure due to activation knob breakage.The product said to be involved is included in the scope of the supplier corrective action request.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• 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: 21207605
• Report Number: 1037905-2025-00071
• Device Sequence Number: 3943659
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)270722(10)W4855699
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

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: 12/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE-UNKNOWN MAKE OR MODEL
• Patient Sex: Unknown