MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUCTION AND COAG.CANNULA,L. 36 CM; ENDOSCOPIC ELECTROSURGICAL ELECT

Model Number	37370DH
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during the laparoscopy, the electric hook was used, but when the electricity was first triggered, the hook fell off.It had to be removed separately from the abdominal cavity, fortunately, it was found immediately.Additional patient information is not available.

• Brand Name: SUCTION AND COAG.CANNULA,L. 36 CM
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16452852
• Report Number: 2020550-2023-00047
• Device Sequence Number: 5835411
• Product Code: GEI
• UDI-Device Identifier: 04048551155646
• UDI-Public: 4048551155646
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2023
• Report Date (Section F): 02/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 37370DH
• Device Catalogue Number: 37370DH
• Device Lot Number: PP01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2023
• 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 Sex: Unknown