MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ULTRAMICRO NEEDLE HOLDER, 30 CM; NEEDLE HOLDER, REUSABLE

Model Number	26167FN
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that there was an issue with ultramicro needle holder, 30 cm, during surgery.According to the complaint description a metal fragment was found in situ during surgery.The needle holder was used to suture the colon wall (sigma).After finishing the suture, the presence of a metal fragment on the wall of an intestinal loop was found and it was removed.The consequence was a prolonged surgery time and execution of abdominal x-ray.The surgery was completed successfully and no negative impact on the state of health was reported.
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The item in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information: the procedure was prolonged for about one hour due to the event reported.The initial anticipated surgery time is unknown.
Event or Problem Description
The procedure was prolonged for about one hour due to the event reported.The initial anticipated surgery time is unknown.
Additional Manufacturer Narrative
The complaint product was available for investigation.Visual examination revealed that the carbide tip is missing from on jaw and a part of the tip was broken off.In addition, dents, a small missing piece of the tungsten cartridge and the solder is missing in various places of the device jaw.No abnormalities were found for the manufacturing inspection lot.A review of the complaint history revealed that one similar incident has been filed against this article number.Based on the investigation results, the root cause of the reported issue can be traced back to a usage-related failure.Specifically, it is assumed that the damages found with the device affected the solder connection between the jaw and the cartridge plate negatively.Furthermore, it is assumed that mechanical damage was caused by using e.G.Not approved suture material and/or the device was steam sterilized longer and with higher temperatures as mentioned in the corresponding ifu.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ULTRAMICRO NEEDLE HOLDER, 30 CM
• Common Device Name: NEEDLE HOLDER, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA
• MDR Report Key: 16599565
• Report Number: 9610617-2023-00066
• Device Sequence Number: 12303314
• Product Code: GCJ
• UDI-Device Identifier: 04048551095348
• UDI-Public: 4048551095348
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/10/2023

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: 26167FN
• Device Catalogue Number: 26167FN
• Device Lot Number: DA061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 03/27/2023; 05/16/2023; 07/12/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/24/2023; 05/17/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown