MAUDE Adverse Event Report: COOK MEDICAL COOK SHORT SHOT BANDING; HEMORRHOID BANDING

Model Number HMBL-4

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  Injury  

Event Description

Patient presented to hospital for outpatient surgery for procedure of colonoscopy, hemorrhoidectomy and banding of internal hemorrhoids and excision of intragluteal skin tag.A short shot banding instrument was used for banding or some of the internal hemorrhoids.During the procedure, it was reported that the short shot hemorrhoid banding misfired on the third use.Cook hmbl-4 (b)(4).No patient injury occurred.New short shot obtained to complete surgery.The patient was not reported with injury and no other complications.

• Brand Name: COOK SHORT SHOT BANDING
• Type of Device: HEMORRHOID BANDING
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 4825127
• MDR Text Key: 5906576
• Report Number: MW5042967
• Device Sequence Number: 1
• Product Code: FHN
• 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: 05/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HMBL-4
• Device Catalogue Number: HMBL-4
• Device Lot Number: W3502878
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR
• Patient Weight: 68