MAUDE Adverse Event Report: DEPUY MITEK, LLC; ACCESSORIES, ARTHROSCOPIC

Model Number 251723

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2018

Event Type  malfunction  

Event Description

The grasper would not retract.

• Brand Name: NA
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK, LLC; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 8037139
• MDR Text Key: 126085056
• Report Number: 8037139
• Device Sequence Number: 1
• Product Code: NBH
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 251723
• Device Catalogue Number: 251723
• Device Lot Number: L973661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2018
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Weight: 66