MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Model Number 26040GP1-S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

While performing turp procedure, the surgeon reported that the bipolar cutting loop broke into pieces inside the patient.The fragmented pieces were removed.Manufacturer response for coagulator-cutter, endoscopic, bipolar (and accessories), n.A.(per site reporter).The representative was notified via telephone.

• Brand Name: N.A.
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 78532 tuttlingen germany; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 10612661
• MDR Text Key: 209391815
• Report Number: 10612661
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 04048551392737
• UDI-Public: (01)04048551392737
• 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: 09/08/2020

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: 26040GP1-S
• Device Catalogue Number: 26040GP1-S
• Device Lot Number: 37JI1023
• 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: 09/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32120 DA