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

Model Number 27040GP1

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is pending.Actions will be implemented by the manufacturer as required.The affected product has been received and it will now be determined what further investigations need to be conducted.".

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): initially received information: "resection with bipolar loop of trilobed prostatic adenoma.Extracting the loop we find the lack of the bipolar loop.Hemostasis of the lodge.Prostatic bed.After numerous unsuccessful attempts to retrieve the loop section, because of poor visibility due to low bleeding, it was decided to stop the procedure." "incident consequence: specific medical intervention." further information received: "-on (b)(6) the patient underwent a flexible urethrocystoscopy for a scheduled check-up (however, in conditions of absolute well-being, no fever, no dysuria, no haematuria).During the investigation, the fragment of a bipolar resection loop that had "broken off" during surgery on (b)(6) 2021 was found at the bulbar urethra.This fragment was extracted completely.Subsequent urethral and bladder inspection did not document any other fragments.The patient was informed about the removal of the fragment.A follow-up visit has been scheduled in about 2 weeks." (b)(4).

Manufacturer Narrative

An investigation of the returned 27040gp1 bipolar cutting loop (lot: uo17, manufacturing month & year: july 2021) was conducted.During the investigation the alleged damage could be confirmed.A piece of the wire has broken off from the active electrode at the distal end and a part of the yellow insulation material has also come off with the wire.On one side of the active electrode the yellow insulation part is still attached.Through the insulation material it can be seen that also a part of the wire is still there and it is visible where the wire has broken.As stated above, the rest of the wire, as well as the yellow insulation part on the other side of the active electrode, have come off and are missing.Based on the damage found, it can be concluded that the most probable root cause is that a too high force was applied, which led to a mechanical overload and breakage of the wire on one side of the active electrode.In turn, the break and force effects on this side of the active electrode caused the wire to come off on the other side.So mechanical damage/ overload during use is concluded as the most probable root cause.In the corresponding instruction manual of the affected product the following safety relevant warning can be found: "warning: risk of injury: overloading the instrument by exerting too much force may cause the medical device to break, bend, and malfunction, and consequently injure the patient or user.Do not overload the instruments.Do not bend bent instruments back to their original positions.".

• Brand Name: CUTTING LOOP, BIPOLAR, 24/26 FR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE
• 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: anja fair ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 12861532
• MDR Text Key: 285621452
• Report Number: 9610617-2021-00075
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04048551393482
• UDI-Public: 4048551393482
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• 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
• Device Lot Number: UO17
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male