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

Model Number	26173KL
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On march 23, 2022, six 26173kl were returned by the customer.The returned products have been evaluated.The product shows signs of third-party repair.Judging by the markings and discoloration, the instrument was not reassembled correctly.The screws also show signs of use, as they would not be delivered by karl storz.There are also signs of use behind the inlay, indicating that the needle was held behind the insert.In this case, much more force must be applied to work with the instrument than would be required if it were used correctly.If too much force is applied, the insert may fall off, and/or the tie rod may break according to our instructions of use.
Event or Problem Description
According to the customer report to the swedish medical product agency: a small piece of metal repeatedly detached from the handrail on the needle driver.The piece of metal had detached on 5 occasions.The small piece of metal may have ended up in the patient's abdomen.The small piece of metal may have ended up in the patient's abdomen.A small metal part has been located and removed.T is unknown if another piece of metal was not recovered from the patient's body.No patient harm has been noted.The customer complains that the pull rod brakes frequently and requests further analysis.No patient involvement was reported.Internal reference number: (b)(4).

• Brand Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 15659012
• Report Number: 2020550-2022-00291
• Device Sequence Number: 6377299
• Product Code: GCJ
• UDI-Device Identifier: 04048551001110
• UDI-Public: 4048551001110
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2022
• Report Date (Section F): 10/18/2022

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: 26173KL
• Device Catalogue Number: 26173KL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2022
• 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 Sex: Unknown