MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, 5 FR.

Model Number 26160SHW

Device Problems Crack (1135); Material Fragmentation (1261)

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

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

It was reported that fragment was identified in the uterus when viewed on the monitor during the cervical procedure with the 26160shw(zp02).The procedure was delayed to identify and remove the debris; however, the debris was very fine and could not be removed.There has been no impact on the patient so far.

• Brand Name: SCISSORS, 5 FR.
• Type of Device: SCISSORS, 5 FR.
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17326739
• MDR Text Key: 319189436
• Report Number: 2020550-2023-00159
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551094655
• UDI-Public: 4048551094655
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2023,07/14/2023

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
• Device Operator: Health Professional
• Device Model Number: 26160SHW
• Device Catalogue Number: 26160SHW
• Device Lot Number: ZP02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other