MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CANNULA SUCTION AND COAGULATION; COAGULATION AND DISSECTION ELECTRODE WITH SUCTION

Model Number 37370DL

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

The product has not been returned at this time, therefore; the product could not be evaluated.

Event Description

Allegedly, during a laparoscopic cholecystectomy procedure, the l hook tip of the electrode fell inside the patient; the doctor was able to retrieve the piece successfully with no harm to the patient and the procedure completed.

• Brand Name: CANNULA SUCTION AND COAGULATION
• Type of Device: COAGULATION AND DISSECTION ELECTRODE WITH SUCTION
• 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 90245 ; 4242188201
• MDR Report Key: 9432345
• MDR Text Key: 193717221
• Report Number: 9610617-2019-00114
• Device Sequence Number: 1
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944862
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37370DL
• Device Catalogue Number: 37370DL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 31 YR
• Patient Weight: 98