MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG; AUTOCLAVABLE FOROBILQUE TELESCOPE

Model Number M3-30A

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, multiple follow ups were made to the user facility in an attempt to gather additional information on the reported event; however, no additional information was obtained.In addition, the telescope was not returned to the service center for evaluation.Therefore, the cause of the reported event cannot be determined at this time.However, if additional information becomes available, or if the device is returned at a later date, this report will be supplemented accordingly.

Event Description

On december 17, 2019 the manufacturer received medwatch report (mw5091350) that states, "during cystoscopy procedure, room staff noted they smelled something burning and patient moaned in pain so cystoscopy scope was removed.The end of the scope was blackened and scope body also had lighter colored black marks on shaft.This scope was used with an olympus light cable and a karl storz light source.This report is for 1 of 2 devices.

Manufacturer Narrative

The risk manager at the user facility further reported the diagnostic cystoscopy procedure was just at the point of completion when the injury was detected as the physician visualized injury through the scope at the end of the procedure.The injury was located on the patient's bladder wall.There was no treatment or longer stay required.The physician noted that the injury presented like a purposeful cauterization and that it would require no intervention to heal.There was no delay in the procedure.The devices were said to have been provided to vendor.The devices were inspected prior to procedure with no anomalies observed.

Event Description

The risk manager at the user facility further reported the diagnostic cystoscopy procedure was just at the point of completion when the injury was detected as the physician visualized injury through the scope at the end of the procedure.The injury was located on the patient's bladder wall.There was no treatment or longer stay required.The physician noted that the injury presented like a purposeful cauterization and that it would require no intervention to heal.There was no delay in the procedure.The devices were said to have been provided to vendor.The devices were inspected prior to procedure with no anomalies observed.

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: AUTOCLAVABLE FOROBILQUE TELESCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 9571369
• MDR Text Key: 174466548
• Report Number: 2951238-2020-00309
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KARL STORZ 201336-20 SERIAL # (B)(6); KARL STORZ LIGHT SOURCE: 201336-20; OLYMPUS LIGHT CABLE: WA03300A; OLYMPUS WA03300A SERIAL # (B)(6)
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 104