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

Model Number	37370DL
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned at this time, therefore; the product could not be evaluated.
Event or Problem 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
• Common Device Name: COAGULATION AND DISSECTION ELECTRODE WITH SUCTION
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9432345
• Report Number: 9610617-2019-00114
• Device Sequence Number: 19477777
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2019

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
• Operator of Device: Health Professional
• Device Model Number: 37370DL
• Device Catalogue Number: 37370DL
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 98