MAUDE Adverse Event Report: STERILMED, INC.; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number ZIM00-8800-000-10

Device Problem Misassembled During Installation (4049)

Patient Problem Tissue Damage (2104)

Event Date 11/29/2018

Event Type  malfunction  

Event Description

The dermatome blade was placed in the dermatome upside down, the width plate was placed over the blade and screwed down, and the skin graft was taken.Unfortunately, a full thickness skin graft was taken instead of the scheduled split thickness skin graft.Because the width of the graft was narrow, the surgeon was able to perform a primary closure of the wound.Although there was a gap between the width plate and the blade (that was noted after the graft was taken), the dermatome performed as usual, except an auditory difference when the dermatome was running.Because there was this gap, the graft thickness was that of full thickness even with the graft thickness set to the desired surgeon's setting.

• Brand Name: NA
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n ste 100; maple grove MN 55369
• MDR Report Key: 8288297
• MDR Text Key: 134495187
• Report Number: 8288297
• Device Sequence Number: 1
• Product Code: GFA
• 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: 01/11/2019

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: Health Professional
• Device Model Number: ZIM00-8800-000-10
• Device Catalogue Number: 00-8800-000-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8030 DA
• Patient Weight: 96