MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED - REPROCESSED CLOSURE SYSTE

Model Number COOCTI-512N

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 07/24/2017

Event Type  malfunction  

Event Description

During a laparoscopic appendectomy procedure, the surgeon attempted to deploy a wound closure device when the device failed in his hand.The closure rod separated from the opening handle assembly.Fascia closure system replaced with new device and defective device set to biomedical for reporting.Surgery completed with no additional incidents.

• Brand Name: NA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED - REPROCESSED CLOSURE SYSTE
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; ste 100; maple grove MN 55369
• MDR Report Key: 6763111
• MDR Text Key: 81690745
• Report Number: 6763111
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/12/2018
• Device Model Number: COOCTI-512N
• Device Catalogue Number: COOCTI-512N
• Device Lot Number: 1992214
• Other Device ID Number: CARTER-THOMASON CLOSESURE SYS
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24 YR