MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR ELECTRODE, 5 FR

Model Number 26159BE

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Per infrastructure's evaluation of the device: the electrode is bent.In the bent area on the outside of the curve, the insulation is shaved off; remaining chips are visible in the damaged area.Conclusion: bent electrode got shaved off--most likely on the edge of a trocar.

Event Description

As per a manufacturer incident report we received from the factory in (b)(6): when the doctor is operating with 26159be bipolar dissecting electrode, middle part of the electrode insulator came off during the procedure, resulting in foreign body in patient's body.Part got retrieved - no harm to patient.

• Brand Name: BIPOLAR ELECTRODE, 5 FR
• Type of Device: BIPOLAR 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: susie chen ; 2151 e. grand avenue; el segundo, ca ; 2188201
• MDR Report Key: 10432052
• MDR Text Key: 204218180
• Report Number: 9610617-2020-00092
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551094228
• UDI-Public: 4048551094228
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K951986
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26159BE
• Device Catalogue Number: 26159BE
• Device Lot Number: TW
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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): Other