MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC 10 SHOOTER SAEED MULTI-BAND LIGATOR; MND, LIGATOR

Catalog Number MBL-U-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Oxygen Saturation (2477); Gastrointestinal Hemorrhage (4476); Swelling/ Edema (4577)

Event Date 01/29/2024

Event Type  Injury  

Event Description

During an endoscopic variceal ligation, evl, the physician used cook 10 shooter saeed multi-band ligator.It was reported that the ligation view is affected by the device as it is too long during endoscope advancement, and friction causes rupture and bleeding of esophageal and gastric varices, posing a risk of suffocation and massive bleeding.The user used a three-lumen and two-bag tube to compress and stop the bleeding in a timely manner.

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.However, a device failure was not reported.The instructions for use (ifu) states, "potential complications associated with gastrointestinal endoscopy including: allergic reaction to medication, aspiration, cardiac arrhythmia or arrest, fever, hemorrhage, hypotension, infection, perforation, respiratory depression or arrest.Those which can occur with esophageal banding including: esophageal perforation, laryngeal laceration, nausea, obstruction, retrosternal pain, stricture formation." prior to distribution, all 6 shooter saeed multi-band ligators are subjected to a visual inspection 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 remote.Corrective action is not warranted at this time based on the quality engineering risk assessment.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: 10 SHOOTER SAEED MULTI-BAND LIGATOR
• Type of Device: MND, LIGATOR
• 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: 18796473
• MDR Text Key: 336408831
• Report Number: 1037905-2024-00114
• Device Sequence Number: 1
• Product Code: MND
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MBL-U-10
• Device Lot Number: W4782668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCOPE, UNKNOWN MAKE AND MODEL