MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATION & DISSECTION ELECTRODE

Model Number 37370DL

Device Problems Break (1069); Fracture (1260)

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

Event Type  malfunction  

Event Description

During operation of ruptured acute appendictis, 1.5cm tip broken off.The hook diathermy was found by scrub nurse after using and cleansing.The breakage of hook tip happened outside patients body.Post surgery x-ray was taken and compared with normal idential hook diathermy.It could be confirmed that no fragment remained in situ patient body so the.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.The root cause most probably is repeated stress overload which resulted in bending and breakage of the hook.No indication for a material or manufacturing related issue found during investigation.The event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: COAGULATION & DISSECTION ELECTRODE
• Type of Device: COAGULATION & DISSECTION ELECTRODE
• 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
• MDR Report Key: 17127380
• MDR Text Key: 317177038
• Report Number: 9610617-2023-00888
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K944862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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
• Device Lot Number: ZR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1