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

Model Number	26173HA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The item in question was sent to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.
Event or Problem Description
As per a manufacturer incident report (b)(4) received from the factory in germany: it was reported that the physician used the device for suture during an ovarian cyst removing surgery on (b)(6) 2022.The tip of the needle holder broke under normal use and fell into the patient's abdomen.In order to retrieve the fallen part, the user prolonged the anesthesia time and used c-arm x-ray to locate the broken jaw.The operation time was extended for more than two hours.The detached part was found successfully.In order to make sure the patient's overall health and safety, the hospitalization was prolonged for 3 days.There were no long term injuries for the patient.
Additional Manufacturer Narrative
The corresponding manufacturer's complaint reference number for this case is (b)(4).Second supplemental report was initiated to correct section g3.
Additional Manufacturer Narrative
The corresponding manufacturer's complaint reference number for this case is (b)(4).The affected 26173ha needle holder was returned to the manufacturer on 2022-08-29 and the investigation was concluded on 2022-09-29.Upon initial inspection of the product, it could be confirmed that it is damaged at the distal end.The fixed jaw part has broken off from the needle holder.During further investigation, it was found that the axle pin which holds the movable jaw in the fixed jaw is visible from the outside.Normally it is not visible here, since it is welded from the outside, but in this case, the welding seam was broken.This indicates that a high force must have been applied for the welding seam to break.In addition, there are impurities and discolorations visible on the needle holder which have led to corrosion around the needle holder where the breakage happened.Therefore, it can be concluded that the material was weakened due to corrosion, which contributed to the breakage of the fixed jaw part when the high force was applied.Consequently, a combination of corrosion and overloading of the jaw part is concluded as the most probable root cause.Based on the impurities and discolorations, it can furthermore be concluded that the reason for the corrosion was that the needle holder was not adequately cleaned and properly dried after reprocessing, allowing residual moisture to accumulate.The ifu includes relevant information regarding the cleaning of the device, and it also warns against overloading by exerting too much force.

• Brand Name: NEEDLE HOLDER
• 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 90245-5017 ; 4242188738
• MDR Report Key: 15323988
• Report Number: 9610617-2022-00258
• Device Sequence Number: 14832378
• Product Code: GCJ
• UDI-Device Identifier: 04048551387405
• UDI-Public: 4048551387405
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2022

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: 26173HA
• Device Catalogue Number: 26173HA
• Device Lot Number: UP01
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/29/2022; 09/29/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/06/2022; 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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