MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INSERT FOR DISMANTLING KOH NEEDLE HOLDER; KOH NEEDLE HOLDER JAWS CURVED RIGHT

Model Number	30173R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the instrument confirmed that one of the jaws on the instrument was missing the carbide piece.Mechanical force and or improper handling could cause the separation.
Event or Problem Description
Allegedly, per the customer during a bariatric procedure the surgeon could not grab the needle, while inspecting the needle driver he noticed the carbide insert on one of the jaws missing.Per the facility it was uncertain if the metal insert was on the jaw in the beginning of the procedure.A search for the metal carbide insert inside the patient was unsuccessful.The procedure was completed using another set, with no further intervention required or harm to the patient.

• Brand Name: INSERT FOR DISMANTLING KOH NEEDLE HOLDER
• Common Device Name: KOH NEEDLE HOLDER JAWS CURVED RIGHT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9774935
• Report Number: 9610617-2020-00029
• Device Sequence Number: 2573774
• Product Code: GCJ
• UDI-Device Identifier: 04048551008898
• UDI-Public: 4048551008898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 30173R
• Device Catalogue Number: 30173R
• Device Lot Number: XQ01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/02/2020
• 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: Required Intervention