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

Model Number 37370DH

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Type  Injury  

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 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.

Manufacturer Narrative

The electrode tip is broken off at the distal end the tip has been bent up.Traces of use can be seen on the entire shaft.The breakage of the electrode tip is also due to excessive force (for example: levering, pressing).In the ifu it is pointed out that increased force can cause damage to the product.Therefore the most probably root cause is user-related.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SUCTION AND COAG.CANNULA,L. 36 CM
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16453016
• MDR Text Key: 310348462
• Report Number: 9610617-2023-10047
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551155646
• UDI-Public: 4048551155646
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K944823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention