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 Insufficient Information (4580)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

During procedure, bipolar loop broke at shaft.

• Brand Name: N.A.
• Type of Device: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e grand ave; el segundo CA 90245
• MDR Report Key: 12868561
• MDR Text Key: 281208026
• Report Number: 12868561
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 04048551392737
• UDI-Public: (01)04048551392737(240)26040GP1-S(17)260402(10)37CA2506
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2021

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: Other
• Device Model Number: 26040GP1-S
• Device Lot Number: 37CA2506
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Hispanic