MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI METAL OUTER SHEATH, INSULATED; ROBI OUTER SHEATH

Model Number 38600

Device Problem Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Item was found the insulation is cut on the shaft and has also failed the hypot test.Evidence of use as the insulation is nicked and cut on the shaft.This type of occurrence most likely is due to stress and overload.

Event Description

Allegedly, the patient was undergoing a hysterectomy procedure and the burn was noticed by dr.(b)(6) at the end of the procedure.The instruments were not exchanged out and the case was completed with no treatment necessary.

• Brand Name: ROBI METAL OUTER SHEATH, INSULATED
• Type of Device: ROBI OUTER SHEATH
• 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: 10915777
• MDR Text Key: 218717683
• Report Number: 9610617-2020-00133
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551328606
• UDI-Public: 4048551328606
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K962030
• 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: 10/27/2020

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: Health Professional
• Device Model Number: 38600
• Device Lot Number: WU47
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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