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

Model Number 37370DL

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

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 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
• Type of Device: MONOPOLAR CANNULA SUCTION AND COAGULATION
• 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: 9210085
• MDR Text Key: 163050161
• Report Number: 9610617-2019-00099
• Device Sequence Number: 1
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 68