MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KOH NEEDLE HOLDER; KOH NEEDLE HOLDER JAWS CURVED LEFT

Model Number	26173KL
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product evaluation found the lock mechanism operates intermittently with signs of wearing on the ratchet's teeth.Product was in use over 6 years.
Event or Problem Description
During a mis myomectomy, the jaws of the needle holder would not disengage from the needle.The case was converted to an "open" procedure.The procedure was completed with no harm to patient with standard post - operative care.

• Brand Name: KOH NEEDLE HOLDER
• Common Device Name: KOH NEEDLE HOLDER JAWS CURVED LEFT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 12475994
• Report Number: 9610617-2021-00064
• Device Sequence Number: 19818246
• Product Code: GCJ
• UDI-Device Identifier: 04048551001110
• UDI-Public: 4048551001110
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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
• Device Lot Number: PU07
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 09/15/2021
• 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 Age: 39 MO