MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, CUTTING, BIPOLAR, STERILE, 24/26FR; BIPOLAR CUTTING LOOP

Model Number 26040JB1

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Device has not been returned to the manufacturer.No further details of the event are available.

Event Description

As per an aer received from (b)(6) by the factory in (b)(4), involving a bipolar cutting loop: break inside the uterus.

• Brand Name: ELECTRODE, CUTTING, BIPOLAR, STERILE, 24/26FR
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10175273
• MDR Text Key: 198339434
• Report Number: 9610617-2020-00074
• Device Sequence Number: 1
• Product Code: HIN
• UDI-Device Identifier: 04048551393161
• UDI-Public: 4048551393161
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/26/2020

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: Health Professional
• Device Model Number: 26040JB1
• Device Catalogue Number: 26040JB1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other