MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI METAL OUTER SHEATH

Model Number	38600
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).This case cross references complaint (b)(4).
Event or Problem Description
It was reported that during a laparoscopic hysterectomy, item sparked inside of patient.There was no one from karl storz to witnessed this.Manager, onsite endoscopy believes it is the insert, and would like all three items evaluated together.Female patient not harmed, case was not delayed.
Additional Manufacturer Narrative
The claimed article was visually inspected, and temperature-related damage was found at the distal end.On closer investigation of the article under a photomicroscope it was found that there was a short circuit between the two halves of the jaws, which generated enough heat to melt the plastic in the vicinity of the short circuit., an evaluation was made for this article with the yn02 solder to determine whether several articles with this solder were affected.The result of the evaluation is that there is only one message.Based on this information and the rejected articles it is likely that it is a user error.The high voltage test documented in the test lot was also inconspicuous.Here, both the contact resistance of max.1.0 ohm and the high voltage itself with 700vdc were measured.The result was unobjectionable.It is therefore probable that the ifu was not adhered to in the reprocessing area or that the article was incorrectly applied at the end of the operation.This event is filed under internal complaint id (b)(4).

• Brand Name: ROBI METAL OUTER SHEATH
• Common Device Name: METAL OUTER SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78523 2; GM 785232
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo
• MDR Report Key: 19912206
• Report Number: 9610617-2024-00246
• Device Sequence Number: 8731357
• Product Code: GEI
• UDI-Device Identifier: 04048551328606
• UDI-Public: 04048551328606
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K962030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38600
• Device Catalogue Number: 38600
• Device Lot Number: XN17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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
• Concomitant Medical Products and Therapy/Usage Dates: FORCEPS INSERT ITEM # 38610MD YN02.; PLASTIC HANDLE ITEM # 38151 LOT WN19.
• Patient Sex: Female