MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL OUTER SHEATH, INSULATED, 36 CM

Model Number	33300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the instrument was checked for functionality before being handed over.No damage was found.After the instrument was inserted, the branch was opened to lift the tube.The instrument jumped out of the holder and a metal splitter flew into the field of vision.The grasping forceps could no longer be opened or closed using the handle.After the metal splinter was recovered, it was held against the defective area.It was noticed that this was only half of an otherwise closed ring.A laparoscopic search was made for the missing part.Nothing was found.The patient's pelvis was then x-rayed.There were no abnormalities here either.
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).
Additional Manufacturer Narrative
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
This mdr is to provide clarifications/corrections as well as an evaluation summary.Corrections are made in sections d1, d2, and d4 of this mdr.During the investigation it was found that the damage reported by the customer is on the metal outer sheath (article 33300, lot: unknown) and not on the clickline forceps insert (article 33310c, lot: ps07) as initially assumed.Investigation findings for article 33310c - clickline forceps insert: signs of wear were found on the entire surface, but the function is given.Investigation findings for article 33300 - metal outer sheath, insulated, 36 cm: the two bayonet catches at the distal end are broken out and one broken out part was also returned.There is an o-ring on the proximal end that is not from karl storz and another laser marking on the metal insert which is also not from karl storz.The karl storz lot-number is not visible anymore on article 33300, so the exact manufacturing date cannot be determined.According to the other karl storz labeling that is still visible on the article it can only be determined that the shaft must have been produced between (b)(6)2005 and (b)(6) 2014.Age-related traces can also be seen on the insulation (scratches).Conclusion: since there is an o-ring and a laser marking on the metal outer sheath which are not from karl storz, this could indicate a potential repair by a third-party.Based on the investigation, it is concluded that the most probable cause for the damage could be a combination of the age and number of reprocessing of the article, potentially together with an application of excessive force and a third-party repair.Internal karl storz reference number: (b)(4).

• Brand Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Common Device Name: METAL OUTER SHEATH
• 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: 18120304
• Report Number: 9610617-2023-00371
• Device Sequence Number: 7609826
• Product Code: GCJ
• UDI-Device Identifier: 04048551134092
• UDI-Public: 4048551134092
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2024

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: 33300
• Device Catalogue Number: 33300
• Device Lot Number: PS07
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 11/15/2023; 01/17/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/06/2023; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 33310C - LOT: PS07
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown