MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS; CLICKLINE FORCEPS INSERT

Model Number	33310HM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a small pin from the inside of the device came off and was lost in the abdomen when the instrument was used during a procedure.Xray were called to help to locate the pin.The pin was located and successfully retrieved.The instrument was in working order prior to this.It was checked by the scrub nurse and used by the surgeon before the pin came loose.
Additional Manufacturer Narrative
The device 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).

• Brand Name: RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS
• Common Device Name: CLICKLINE FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 19837529
• Report Number: 2020550-2024-00228
• Device Sequence Number: 17804435
• Product Code: GCJ
• UDI-Device Identifier: 04048551134283
• UDI-Public: 04048551134283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/26/2024
• Report Date (Section F): 07/26/2024

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: 33310HM
• Device Catalogue Number: 33310HM
• Device Lot Number: IF1515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/25/2024
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• 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: Required Intervention
• Patient Sex: Unknown