MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING ELECTRODE; ENDOSCOPIC ELECTROSURGERY ELECTRODE

Model Number 27770D

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/05/2019

Event Type  Injury  

Event Description

It was reported that there was event with a coagulating electrode.According to the information received, the patient was undergoing a vaaft procedure and the tip of the diathermy probe became detached inside the patient's fistula tract.It could not be found after searching thoroughly, extensive washing of the cavity was performed throughout the procedure and given the tiny size of the part lost, would not be seen by xray.It is likely to have been washed into suction bag.Too small to locate.Patient informed.Tract was left open as standard in any case.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0052 corrective action 6.Device was not returned for evaluation, therefore a root cause analysis is not possible.No similar incidents with this type of medical device known.No indication for a product or manufacturing issue.No systematic error.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: COAGULATING ELECTRODE
• Type of Device: ENDOSCOPIC ELECTROSURGERY ELECTRODE
• 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
• MDR Report Key: 16950070
• MDR Text Key: 315425752
• Report Number: 9610617-2023-00630
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2017
• Device Model Number: 27770D
• Device Catalogue Number: 27770D
• Device Lot Number: OS05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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