MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 'KOH' NEEDLE HOLDER

Model Number	26173KAF
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The needle holder device was evaluated.We found one of the pads of the needle holder device is missing, the jaws and jaws linkage are corroded, and the shaft is bent.The device was in use for approximately 11 years; the most like cause of damages is wear of use.
Event or Problem Description
Allegedly, the day after a laparoscopic heller myotomy procedure, a follow-up x-ray was performed on the patient, which showed a piece of the needle holder used in the procedure was inside the patient's upper abdomen.The doctor felt it was relatively small and decided not to schedule another surgery to retrieve it at this time.

• Brand Name: 'KOH' NEEDLE HOLDER
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 7631902
• Report Number: 9610617-2018-00041
• Device Sequence Number: 1818882
• Product Code: GCJ
• UDI-Device Identifier: 04048551098097
• UDI-Public: 4048551098097
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 26173KAF
• Device Catalogue Number: 26173KAF
• Device Lot Number: DC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/22/2018
• 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: 12 YR