MAUDE Adverse Event Report: GREENWALD SURGICAL COMPANY, INC. GREENWALD SURGICAL CO., INC.; FLEXIBLE ENDOSCOPIC ELECT., BUGBEE TIP

Model Number 26502-52

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

Patient Problem Insufficient Information (4580)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

Broken bugbee item, from "uro" manufacturer.Very little information to go on with no packaging.Item was reprocessed.Only one onsite at time of the event.

• Brand Name: GREENWALD SURGICAL CO., INC.
• Type of Device: FLEXIBLE ENDOSCOPIC ELECT., BUGBEE TIP
• Manufacturer (Section D): GREENWALD SURGICAL COMPANY, INC.; 2688 dekalb street; lake station IN 46405 1519
• MDR Report Key: 11974556
• MDR Text Key: 280459591
• Report Number: 1818662-2021-00002
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: K933174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 04/30/2021

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: No Information
• Device Model Number: 26502-52
• Device Catalogue Number: EET107B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 92 YR