MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. COOK 4,6,10 SHOOTERSAEED MULTI BAND LIGATOR; LIGATOR, ESOPHAGEAL

Lot Number W4503578

Device Problems Loose or Intermittent Connection (1371); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2022

Event Type  malfunction  

Event Description

Bander g31917+ 4,6,10 shooter:saeed multi-band ligator lot# w4503578 when deployed the bands were loose and twisted.Fda safety report id # (b)(4).

• Brand Name: COOK 4,6,10 SHOOTERSAEED MULTI BAND LIGATOR
• Type of Device: LIGATOR, ESOPHAGEAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.
• MDR Report Key: 14160174
• MDR Text Key: 289878285
• Report Number: MW5109148
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: W4503578
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other