MAUDE Adverse Event Report: SLATER ENDOSCOPY LLC ENSIZOR; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Model Number ES26235

Device Problem Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

We were using endoscopic scissors to remove the cinch from a previously sutured area in the esophagus.We put the endo scissors down the scope but then could not close the scissors.It was observed that the pair of scissors had malfunctioned and were unable to be used anymore.Therefore, we had to remove the scope to manually close the scissors.Then we had to get another pair of endo scissors to complete the task.

• Brand Name: ENSIZOR
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): SLATER ENDOSCOPY LLC; 10306 usa today way; miramar FL 33025
• MDR Report Key: 14874143
• MDR Text Key: 295055497
• Report Number: 14874143
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ES26235
• Device Catalogue Number: ES26235
• Device Lot Number: 00496
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female