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	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an esophagogastroduodenoscopy (egd) procedure to treat an active bleed in the stomach and duodenal bulb, the physician used a cook hemospray endoscopic hemostat.The tech stated when he activated the device, there was a loud air pop and he held the device as tight as he could to stop it from exploding.He described the force as ¿very aggressive and hard to contain¿, his hand took the brunt of the force, and no serious injury occurred.Per the cook sales rep, the activation knob was missing the threading on the inside and the plastic was visibly cracked.The product did not make patient contact.The procedure was completed with another of the same device that did not share the same lot number.This occurred prior to patient contact; there was no impact to the patient.In addition, the patient sustained no clinical consequence and there were no adverse effects to the patient.
Additional Manufacturer Narrative
Continued: section g: 510k: k200972.Investigation evaluation: the product said to be involved was returned in an open tray 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.Both catheters were included in the return and neither showed signs of use (no discoloration, powder within, or kinks were noted).The co2 cartridge was observed to be moving freely within the tray.The device was returned with the on/off switch in the "on" position.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.The white body of the handle has not broken open.Powder was observed on the exterior of the returned components, within the device nozzle, and within the tray.The red activation knob was returned reinserted into 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 has popped and the white o-ring remains fixed in the handle.The co2 cartridge was returned and was 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 066-r.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 res 95300) has been initiated for this nonconformance; the reported lot, w4849973, 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.

• 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: 20259079
• Report Number: 1037905-2024-00558
• Device Sequence Number: 8014235
• Product Code: QAU
• UDI-Device Identifier: 00827002210493
• UDI-Public: (01)00827002210493(17)270628(10)W4849973
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/19/2024

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: W4849973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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: OLYMPUS THERAPEUTIC SINGLE CHANNEL SCOPE
• Patient Sex: Unknown