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

Model Number 27040GP1

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/10/2022

Event Type  Injury  

Manufacturer Narrative

Karl storz was informed about an event involving a cutting loop.Furthermore, we have been informed that the involved instrument has already been scrapped.A detailed investigation of the product and an exact root cause determination is therefore not possible.However, based on the customer[?]s description and evaluated previous complaints it can be concluded that the most probable root cause could be an overload of the loop.Potentially the electrode became too hot due to too long pulses, so the material was damaged, or the loop was already in use several times and has worn out as a result (also indicated by the information provided by the distributor).

Event Description

It was reported that on (b)(6) 2022, during the turb surgery of patient mg in the urology operating room, a rupture was found during the introduction of the medical device.The loop was then removed completely but a small piece, size of about 1.5 mm, migrated into the bladder with no further possibility of recovery." a piece of the bipolar ansa was broken (for excessive use maybe over 10 uses as described in the manual) this piece moved along the bladder and it has been necessary to increase the procedure for 30 minutes to try to collect the broken piece of ansa with cystoscope.Internal karl storz reference number: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR.
• Type of Device: COAGULATING, CUTTING ELECTRODE, LOOP BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 15953655
• MDR Text Key: 305241982
• Report Number: 9610617-2022-00324
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2022

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: 27040GP1
• Device Catalogue Number: 27040GP1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other