MAUDE Adverse Event Report: GREENWALD SURGICAL COMPANY, INC. GREENWALD SURGICAL CO, INC.; BALL TIP ELECTRODE FOR RIGID CYSTOSCOPES

Model Number 25910-06

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

Describe the evento or problem: urologist using bugby ball tip electrode.When he removed it from the patient, he noticed the ball tip was missing.Upon inspection, the surgeon located the ball tip adhered to the bladder.He was able to retrieve the ball tip with no harm to the patient.What was the original intended procedure? : cystoscopy, bladder biopsy and fulgeration.What problem did the user have : device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: GREENWALD SURGICAL CO, INC.
• Type of Device: BALL TIP ELECTRODE FOR RIGID CYSTOSCOPES
• Manufacturer (Section D): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station IN 46405 1519
• Manufacturer (Section G): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station IN 46405 1519
• Manufacturer Contact: liz birge ; 614 sr 247; russellville, AR 72802 ; 4799685455
• MDR Report Key: 11814297
• MDR Text Key: 268268922
• Report Number: 1818662-2021-00001
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 10801334000806
• UDI-Public: (01)10801334000806
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K933173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/01/2021

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: 25910-06
• Device Catalogue Number: RET107K
• Device Lot Number: 28468
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR