MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. BIPOLAR CUTTING LOOP, DIAMETER 0.30MM; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 27040GP130-S

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2021

Event Type  malfunction  

Event Description

While doctor was operating when the tip of his bipolar instrument broke off inside of the patient.The broken piece was retrieved and no harm or injury came to the patient.Fda safety report id# (b)(4).

• Brand Name: BIPOLAR CUTTING LOOP, DIAMETER 0.30MM
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; el segundo CA 90245
• MDR Report Key: 12961206
• MDR Text Key: 282036019
• Report Number: MW5105922
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00404855139387
• UDI-Public: 01004048551393871
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2021

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: 27040GP130-S
• Device Lot Number: 37BA2547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Hispanic