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

Model Number 27040G

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Uterine Perforation (2121); Bowel Perforation (2668)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

The concerned medical devices are in transit to the manufacturer for investigation.The investigation is pending.

Event 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)).

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
• Type of Device: 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
• MDR Text Key: 283669245
• Report Number: 9610617-2022-00002
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551393246
• UDI-Public: 4048551393246
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female