MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, BLUNT, 5 FR., 34 CM

Model Number 26159EHW

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

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

Event Date 07/10/2023

Event Type  Injury  

Event Description

Tiny metal fragments (powder-like) were dislodged from the scissors when it was inserted into the patient's uterus via single-flow operating sheath.One larger fragment attempted to be removed but washed out when trying to transfer to the specimen container.

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).

• Brand Name: SCISSORS, BLUNT, 5 FR., 34 CM
• Type of Device: SCISSORS, BLUNT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17491414
• MDR Text Key: 320710106
• Report Number: 2020550-2023-00206
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551094280
• UDI-Public: 4048551094280
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2023

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: 26159EHW
• Device Catalogue Number: 26159EHW
• Device Lot Number: VR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other