MAUDE Adverse Event Report: GYRUS ACMI, INC FULGURATING ELECTRODE, SHORT TIP, 105 CM (6/PKG); ADULT RESECTOSCOPE

Model Number BE-302

Device Problem Excessive Heating (4030)

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

Event Date 03/26/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The user discarded the subject device, therefore the cause of the issue cannot be determined.As stated in the ifu and as a preventive measure, the user manual states : this product is for single use only.It has not been designed to be reused or resterilized.Reprocessing may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation or splitting which may impact the strength of the device and compromise device performance.Reprocessing of single use devices can also cause cross-contamination leading to patient infection.These risks may potentially affect patient safety.Study this manual and other labeling thoroughly for safe handling and storage.Read all instructions carefully, including instructions for all generators and accessories.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.

Event Description

It was reported that during an unspecified procedure, the device be-302 tip burnt.The intended procedure was completed using a laser.There was no patient harm or injury reported due to the event.

Event Description

The intended procedure was a bilateral labiaplasty.No delay in procedure and current condition of the patient is within normal limits.

• Brand Name: FULGURATING ELECTRODE, SHORT TIP, 105 CM (6/PKG)
• Type of Device: ADULT RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10032527
• MDR Text Key: 199503870
• Report Number: 3011050570-2020-00005
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/09/2020

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: Health Professional
• Device Model Number: BE-302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 80