MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE FORCEPS INSERT

Model Number 33310AF

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 patient underwent an uncomplicated laparoscopic appendicectomy.After the operation it was noted that a small rivet (<1mm) was missing from the laparoscopic grasper instrument.No defect was noted by theatrestaff during or after the operation.Details of injury (to patient, carer or healthcare professional): presence of a small <1mm metallic foreign bodyinside the abdominal cavity in the left iliac fossa.On 13/07/21 distributor made aware that the part that detached from the instrument has been confirmed to have been retained inside the patient and has been discovered under x-ray.Revision surgery will be required to remove.No further details available.

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa (bb(4) corrective action 12.Examination of the article: the tong attachment was manufactured in may 2011.The pliers insert has more severe signs of use in the area of the joints and rivets.Presumably, due to the age of 10 years, the rivet head has been heavily stressed in this time.In addition an overload has taken place on the article, because the joint has a bulge of the material which can arise from too high a force transmission.In addition, the following is described in the reprocessing instructions under the point "assembly, testing and care": joints, threads and sliding surfaces are to be specifically maintained with instrument oil and / or special grease.A functional check must then be carried out.The cause is most likely a mechanical overload, of the rivets.No evidence of a material or manufacturing problem was found during the investigation.It must be assumed that the article was used improperly and that the ifu or the reprocessing instructions were not adhered to, thus causing the fault.No further action required as this is a user error.The event is filed under internal karl storz complaint id ((b)(4)).

• Brand Name: CLICKLINE FORCEPS INSERT
• Type of Device: CLICKLINE FORCEPS INSERT
• 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
• MDR Report Key: 17031049
• MDR Text Key: 316379956
• Report Number: 9610617-2023-00683
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K935071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 33310AF
• Device Catalogue Number: 33310AF
• Device Lot Number: SY3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention