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

Model Number	G21049
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.
Event or Problem Description
In preparation for a procedure, the user selected a cook hemospray endoscopic hemostat.It was reported that during activation, the red lever [activation knob] broke and the gas cartridge was pushed out.Photos were provided that show the activation knob of the device broken at the internal threads.This occurred prior to patient contact.At the time of this report, our attempts to collect additional information regarding patient outcome have been unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.Additional attempts to gather this information will be made.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open tray from the lot number provided in the report.The label matches the product returned.Photos provided show the device labeling for the reported lot, a broken portion of the activation knob containing the fully punctured co2 cartridge, and the inside of the handle where it can be observed that a portion of the activation knob has been retained threaded at the regulator and the regulator's lance remains in place.Some cracking is noted along the seam of the white handle.Our laboratory evaluation of the product said to be involved confirmed the report.Not all components were included in the return, the black o-ring was not returned.Only one catheter was included in the return.The returned catheter appeared to be clean without signs of use (no kinks, discoloration, or powder within).The co2 cartridge, red activation knob, and foam were returned moving freely in the tray.The device was returned with the on/off switch in the "off" position.The white body of the handle was noted to be cracked along the inner seam of the handle.Powder was not observed on the exterior of the returned components, within the device nozzle, or within the plastic bag.A portion of the red activation knob remained seated around the regulator in the handle.The point of fracture was noted to have glassy and dull areas.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.A lab meeting with manufacturing engineering was held 25feb2025.During this meeting the device was disassembled and the regulator tubing was removed from the regulator to free it for ease of assessment with the activation knob.When the white body of the handle was opened it was noted that the retained portion of the activation knob had "bottomed out" and with the white handle body's rib being fixed between the regulator and the activation knob.It was noted, during removal of the retained portion, a notable amount of force had to be applied when initially beginning to unthread it from the regulator.Under magnification of the smaller portion it was noted that a faint stress line/crack extended from the notch in the segment, diagonally, until reaching the bottom of the segment.Further investigation found that the threading of both the regulator and activation knob appear to be intact.A small hairline crack was noted extending along the larger segment of the activation knob, which aligned with the location of the crack along the smaller segment.An additional lab meeting was held with manufacturing engineering on 28feb2025.During this meeting an activation knob from our shelf stock was confirmed to thread onto the complaint device's regulator without issue and that it did not "bottom out" when fully tightened and left a small gap between the activation knob and the handle half's rib.It was noted that the foam did not show significant signs of damage but had definitely undergone the pressure of activation due to the deformation observed.Dimensional review of the device components found the co2 cartridge length, the foam height (while deformed), the pertinent dimensions of the white handle, the pertinent dimensions of the regulator, the total length of the complaint regulator, and the lance height to all be within specification.It was noted that the threaded portion of the clear cap on top of the regulator was slightly longer than specified, however it was securely attached, and is not believed to be a contributing factor to the reported occurrence.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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.Additionally, a review of the raw material inspection record was performed and confirmed no cracks were detected during inspection of the activation knob for this lot of raw materials.Investigation conclusion: our laboratory evaluation of the product said to be involved confirmed the report of activation knob breakage.A definitive cause for this observation could not be determined because the actual product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.Our investigation of the complaint piece found pertinent dimensions to be within product specification.Our inspection of incoming raw materials includes a 100% inspection of incoming activation knobs for the presence of cracks or thin areas of the handle.A supplier corrective action request (scar) was initiated to further investigate device failure due to 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.A review of the raw material inspection data confirmed no cracks were detected during the inspection process.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 (COOK ENDOSCOPY); 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC (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: 21548703
• Report Number: 1037905-2025-00198
• Device Sequence Number: 8164550
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)271023(10)W4881778
• Combination Product (Y/N): N
• PMA/510(K) Number: K200972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: W4881778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown