MAUDE Adverse Event Report: GREENWALD SURGICAL CO. INC. BUGBEE TIP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Catalog Number EET107B-02

Device Problems Break (1069); Packaging Problem (3007)

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 event.

• Brand Name: BUGBEE TIP
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GREENWALD SURGICAL CO. INC.; 2688 dekalb st; lake station IN 46405
• MDR Report Key: 11811739
• MDR Text Key: 250279955
• Report Number: 11811739
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2021,04/27/2021

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 Catalogue Number: EET107B-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2021
• Device Age: 4 YR
• Date Report to Manufacturer: 05/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33580 DA