MAUDE Adverse Event Report: STERILMED, INC.; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC

Model Number MIC3152

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2019

Event Type  malfunction  

Event Description

During laparoscopic procedure, a protective sheath from the laparoscopic mini scissor tip (reprocessed oem ref # mic3152, lot# 2094141) came off the scissor tip inside patient abdomen.Sheath removed in one piece by the doctor, removed from sterile field.Imaging taken at end of case and showed no retained items seen on xray.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, LAPAROSCOPIC
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 9192767
• MDR Text Key: 162352532
• Report Number: 9192767
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2019,09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MIC3152
• Device Catalogue Number: MIC3152
• Device Lot Number: 2094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA