MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. M/L-10; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 1002

Device Problem Failure to Advance (2524)

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

Event Date 01/06/2020

Event Type  malfunction  

Event Description

Microline clip applier possibly malfunctioned.Some clips did not stay attached when other clips were placed adjacent to them.

• Brand Name: M/L-10
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MICROLINE SURGICAL, INC.; 50 dunham rd; beverly MD 01915
• MDR Report Key: 9865027
• MDR Text Key: 184482094
• Report Number: 9865027
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1002
• Device Catalogue Number: 1002
• Device Lot Number: 00126772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA