MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO NEEDLE HOLDER, 5 MM, 33 CM

Model Number 26173KAL

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

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

Event Type  Injury  

Event Description

It was reported that after completing the surgery on the patient, the surgeon noticed that the tip of the needle holder was broken.After the surgery, an x-ray examination confirmed that the damaged fragment remained.It will be collected.The broken tip remained in patient and a further surgery to recover the piece is likely.

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: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Type of Device: MACRO NEEDLE HOLDER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 17836795
• MDR Text Key: 324510359
• Report Number: 2020550-2023-00271
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04048551098127
• UDI-Public: 4048551098127
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/28/2023

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: 26173KAL
• Device Catalogue Number: 26173KAL
• Device Lot Number: W06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other