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

Model Number UNKNOWN

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Abdominal Pain (1685); Insufficient Information (4580)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

It was reported that a piece of a bipolar forceps broke off during surgery.The patient consequences remain unknown to date, but negative consequences cannot be ruled out completely.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

Manufacturer Narrative

As the device in question was not returned by the customer, an investigation on the product itself could not be performed.However, the available information as well as a picture has been reviewed.The investigation was completed on 2023-11-16.According to the customer's description, a part of the insulation (approx.6 cm x 0,2 cm) was found 15 months after the primary surgery in the patient.Presumably, the fragment originates from a 33300 - metal outer sheath, insulated, 36 cm.However, there is no clear evidence regarding the article number.A possible cause of the separation of the insulation could have been that the shaft was pulled out of a trocar at an specific angle, causing an edge of the trocar to peel off the insulation of the shaft.It is not known whether other instruments were in use at the same time.Hence, it is not possible to determine the exact cause of the failure pattern.In addition, it is not known how long the related article has been in use.Therefore, it may also have signs of use, wear and tear commensurate with its usage and service life.As the items must be checked for completeness after every use, any degradation or missing parts should have been noticed immediately after the surgery at the latest.Internal karl storz reference number:(b)(4).

Manufacturer Narrative

Further information received on 22-september-2023 provided in sections a2, a3, b5 and h6.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

During an intervention (hyteroscopy and laparoscopy) on (b)(6) 2020 at the landeskrankenhaus hall (tirol kliniken) for the diagnosis and treatment of endometriosis, part of the outer shaft of a bipolar grasping forceps detached and remained unnoticed in situ.In the course of another laparoscopic intervention on 07.03.2022 in the landeskrankenhaus hall, the surgeons found the foreign body (approx.6 cm x 0.2 cm) intraoperatively and removed it.

• Brand Name: BIPOLAR FORCEPS
• Type of Device: BIPOLAR FORCEPS
• 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: 17452707
• MDR Text Key: 320399056
• Report Number: 9610617-2023-00200
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K962030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female