MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR 24/26FR LOGITUDINL

Model Number	27040JB130-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not return to the manufacturing site for investigation due to the facility cannot find the cutting loop.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).
Event or Problem Description
It was reported that dr.(b)(6) who are one of our or doctors, noted the metal cutting loop - of the storz bipolar longitudinal cutting loop, diameter 0.30mm 24/26 fr lot:37ld8996, exp 2030-01-03, became lost during surgery.Dr (b)(6) was unable to locate the missing piece thus she ordered a stat portable x-ray of pelvis, intra-op xray performed, per radiologist, x-ray confirms there is no retained object in patient.This was being used with the large resectoscope and the cutting loop completely detached from both sides during the procedure while simply using the scope to observe the uterine cavity and not applying any pulling/pushing or cautery to the loop.This was recognized promptly, and the instrument was removed.A thorough search of the patient/drapes/vagina/tubing/fluid management was performed, and the loop was not identified.

• Brand Name: CUTTING LOOP, BIPOLAR 24/26FR LOGITUDINL
• Common Device Name: CUTTING LOOP, BIPOLAR 24/26FR LOGITUDINL
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• MDR Report Key: 24457489
• Report Number: 2020550-2026-00384
• Device Sequence Number: 13274762
• Product Code: FAS
• UDI-Device Identifier: 04048551393888
• UDI-Public: 04048551393888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026
• Report Date (Section F): 02/26/2026

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
• Operator of Device: Health Professional
• Device Model Number: 27040JB130-01
• Device Catalogue Number: 27040JB130-01
• Device Lot Number: 37LD8996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/11/2026
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 81 KG