MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING ELECTRODE, ANGLED.24FR

Model Number	27040G
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Uterine Perforation (2121); Bowel Perforation (2668)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The concerned medical devices are in transit to the manufacturer for investigation.The investigation is pending.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): as reported: "colonic perforation posterior side of uterus discovered 24 hours later." currently no further information regarding health effects available.A 26040sl resectoscope sheath and an inner sheath 27040xa were involved.No indication of malfunction of the product.(manufacturer's internal complaint #(b)(4)).
Additional Manufacturer Narrative
The affected products were received by the manufacturing site in germany on (b)(6) 2022 for investigation.During the evaluation it was determined that the optic sent in by the customer is a third party product.The article 27040e/working element is a karl storz product but has also a third-party inscription on the shaft, which proves that the article was repaired by a third party.Two of the electrodes are bent, which indicates that force was applied without activating.All other devices which were sent in by the customer showed no defects apart from normal signs of use.Under certain circumstances, a combination of a foreign optics and a foreign repair can promote damage or improper functioning of the instruments.No indication for a material or manufacturing related issue was found during the investigation.The detected error concerns only the electrode (27040g); therefore, the device in this supplement report has been changed to the 27040g electrode.Following is a list of accessories used for the case: 27040xa - inner sheath - karl storz.26040sl - resectoscope shaft, 26 charr.- karl storz.27040e - working element - karl storz.27040g - cutting snare, angled, 24 charr.- karl storz.27040vg - spike electrode, 24 charr.- karl storz.27040n - coagulation electrode, 24 charr.- karl storz.27040l - coagulation electrode, 24 charr.- karl storz.27068k - knife, straight - karl storz.27040oc - standard obturator - karl storz.27021o - filling rod for 27026e/ef/eg/eh - karl storz.26163v - examination shaft, ø 5.1 mm - karl storz.279 - unipolar high-frequency cable, 300 cm - karl storz.495na - fiberoptic light cable 230cm/ø 3.5mm - karl storz.Hf sclapel embe - batch #112-83-884 //.Hf scalpel erbe - batch #112-83-884.Ak - optic.

• Brand Name: CUTTING ELECTRODE, ANGLED.24FR
• Common Device Name: CUTTING ELECTRODE
• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 13235990
• Report Number: 9610617-2022-00002
• Device Sequence Number: 4610318
• Product Code: HIH
• UDI-Device Identifier: 04048551393246
• UDI-Public: 4048551393246
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27040G
• Device Catalogue Number: 27040G-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2001
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female