MAUDE Adverse Event Report: GYRUS ACMI, INC.; FORCEPS, BIOPSY

Model Number E8213

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Event Description

While instrument was used by surgeon, the bladder biopsy forcep broke inside the patient's bladder.During the procedure, the bladder was irrigated with sorbital.The doctor stated that after examining the bladder there was no harm and no retained pieces of the instrument.

• Type of Device: FORCEPS, BIOPSY
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• MDR Report Key: 8334711
• MDR Text Key: 136017062
• Report Number: 8334711
• Device Sequence Number: 1
• Product Code: GEN
• 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: 02/05/2019,12/26/2018

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: E8213
• Device Catalogue Number: E8213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Date Report to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2019
• Type of Device Usage: N
• Patient Sequence Number: 1