MAUDE Adverse Event Report: KARL STORZ GMBH & CO. BIPOLAR ELECTRODES; BIPOLAR CUTTING LOOP

Model Number 26040GP1

Device Problems Material Separation (1562); Arcing of Electrodes (2289)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

Allegedly, the doctor was performing a small fibroid removal, but discovered during the case a very large, vascular myoma that had grown into the uterine wall.The doctor experienced difficulties in addressing this condition resulting in excessive bleeding, extended procedure time, a perforated uterus and hospitalization.During the procedure, the electrode arced and broke and the loop fell into the pt.The doctor retrieved the piece.The broken electrode did not cause the bleeding, extended procedure time, perforated uterus or hospitalization.

Manufacturer Narrative

It is possible that too much stress was applied to the electrode during use resulting in arcing and detachment of the loop.

• Brand Name: BIPOLAR ELECTRODES
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ GMBH & CO.; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen ; GM
• Manufacturer Contact: susie ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4298218
• MDR Text Key: 15821265
• Report Number: 9610617-2014-00059
• Device Sequence Number: 1
• Product Code: HIN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2014

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: 26040GP1
• Device Catalogue Number: 26040GP1
• Device Lot Number: 48403
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR