MAUDE Adverse Event Report: KARL STORZ SE & CO. KG TUBE,OUTER,INSULATED, 5MM. 36CM, WITH; OUTER TUBE

Model Number 33300

Device Problem Mechanical Problem (1384)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

An on-site inspection took place and the retrieved foreign piece appears to be a locking mechanism at the distal end of the tube to lock the insert.

Event Description

Per our customer, the initial surgery was a lap cholecystectomy performed on (b)(6) 2019.The customer explained "a second surgery was performed on (b)(6) 2019, as the patient complained of abdominal pain, at which time they underwent an abdominal x-ray, and the foreign body was discovered.The purpose of the second surgery was to remove the foreign body." they did not know before the patient came back to the hospital that there was a foreign body inside the patient.The surgeon and or staff did not observe the piece falling off the instrument during the case and subsequently staff didn't notice that something was missing from the instrument, the item was returned to us as routine repair.

• Brand Name: TUBE,OUTER,INSULATED, 5MM. 36CM, WITH
• Type of Device: OUTER TUBE
• 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 east grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9215250
• MDR Text Key: 194174770
• Report Number: 9610617-2019-00100
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 4048551002308
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 33300
• Device Lot Number: RS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1