MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; LAPAROSCOPY KIT

Model Number DYNJ57889A

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

Patient Problem Burn(s) (1757)

Event Date 05/12/2020

Event Type  malfunction  

Event Description

Cautery blade touched metal retractor during incarcerated inguinal hernia repair case.Small burn noted distal to the incision.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 10095789
• MDR Text Key: 192398088
• Report Number: 10095789
• Device Sequence Number: 1
• Product Code: FDE
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ57889A
• Device Catalogue Number: DYNJ57889A
• Device Lot Number: 20BLA351
• 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: 05/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA