MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. INSTINCT ENDOSCOPIC CLIP; HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number INSC-7-230-S

Device Problems Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Firing Problem (4011)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/22/2021

Event Type  Injury  

Event Description

Cook model# insc-7-230-s used at biopsy site during an endoscopy procedure.Hemoclip applier failed to discharge properly.Unable to ligate the blood vessel and stop bleeding.The bleeding was minimal and continuous.Pt was transferred to higher level of care for observation.Fda safety report id # (b)(4).

• Brand Name: INSTINCT ENDOSCOPIC CLIP
• Type of Device: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.
• MDR Report Key: 12540065
• MDR Text Key: 273786003
• Report Number: MW5104224
• Device Sequence Number: 1
• Product Code: PKL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSC-7-230-S
• Device Catalogue Number: G18343
• Device Lot Number: W4452923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR
• Patient Weight: 63