MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MORCELLATOR BLADE, DIA. 4 MM, LGTH 40 CM; TISSUE MORCELLATION SYSTEM

Model Number	27056LM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on tuesday, (b)(6) 2023, themorcellator system did not work 100% correctly, which caused the procedure to be cancelled.According to the doctor the patient was not injured.
Additional Manufacturer Narrative
The item in question was disposed and not returned to the manufacturer.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The product was not returned to manufacture.The investigation was completed on 17 august 2023.Based on the pictures sent by the customer, the analysis shows that an o-ring is missing inside in the proximal area.The ring is responsible for the sealing.This probably fell out during reprocessing and was not noticed by the user.According to the reprocessing instruction 27056lm_en_v48.2_03-2023_ri_ce, it is pointed out to check the article for completeness before and after use, otherwise supplement or exchange the article.Because the article was not returned for examination, no deeper investigation is possible.Since the procedure was cancelled due to device issue, therefore this case is reportable the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MORCELLATOR BLADE, DIA. 4 MM, LGTH 40 CM
• Common Device Name: TISSUE MORCELLATION SYSTEM
• 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: 17075551
• Report Number: 9610617-2023-00121
• Device Sequence Number: 17812289
• Product Code: GCJ
• UDI-Device Identifier: 04048438002865
• UDI-Public: 4048438002865
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27056LM
• Device Catalogue Number: 27056LM
• Device Lot Number: NP01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown