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

Model Number	37370DL
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned, therefore we did not evaluate at this time.If the product is returned an evaluation will take place.This is a "l" hook and breakage most likely was the l hook which broke off from the cannula.
Event or Problem Description
Allegedly per the customer, during a laparoscopic sigmoid resection the instrument disintegrated, item broke at tip while inside the patient.The piece was removed and the procedure was completed with no other intervention and no harm to the patient.

• Brand Name: CANNULA SUCTION AND COAGULATION
• Common Device Name: MONOPOLAR CANNULA SUCTION AND COAGULATION
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9210085
• Report Number: 9610617-2019-00099
• Device Sequence Number: 11550012
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 10/17/2019

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/18/2019
• 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: 50 YR
• Patient Weight: 68