MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY NEEDLE HOLDER

Model Number	26167FNS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject instrument was not returned for evaluation.We have not been able to obtain any further details of the event other than what was included in users medwatch report.
Event or Problem Description
Allegedly, during an esophageal repair procedure, a piece of the needle holder broke off inside the patient and was retained.

• Brand Name: NEEDLE HOLDER
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen
• MDR Report Key: 6896192
• Report Number: 9610617-2017-00080
• Device Sequence Number: 496647
• Product Code: GCJ
• UDI-Device Identifier: 04048551095362
• UDI-Public: 4048551095362
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2017

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: 26167FNS
• Device Catalogue Number: 26167FNS
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 MO