MAUDE Adverse Event Report: KARL STORZ SE & CO. KG THERE IS NO NEW INFORMATION FOR THIS FIELD.

Model Number 011160-10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  Injury  

Event Description

It was reported that there was an issue with the product.The cutting element of the loops broke on the first activation.One of the electrodes broke in the patient's bladder.The broken items were recovered directly during surgery and the surgery was prolonged for 30 minutes.Due to the prolongation of the surgery, the patient was hospitalized for one night.The patient condition post-surgery is fine, there was no harm reported.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.Internal karl storz reference number: (b)(4).

Event Description

There is no new information for this field.

• Brand Name: THERE IS NO NEW INFORMATION FOR THIS FIELD.
• Type of Device: THERE IS NO NEW INFORMATION FOR THIS FIELD.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 15925815
• MDR Text Key: 304916602
• Report Number: 2020550-2022-00323
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551411087
• UDI-Public: 4048551411087
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 838048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization