MAUDE Adverse Event Report: KARL STORZ SE & CO. KG OPTICAL FORCEPS, FOR BIOPSY

Model Number	27072A
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cystoscope with biopsy with cysview and ureteroscopy procedure on (b)(6) 2024, a piece of the instrument broke and fell into the patient's bladder.They spent roughly 10 minutes trying to locate the broken piece, but were unable to locate it.There was no direct patient injury reported, and they were able to complete the procedure.
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).
Additional Manufacturer Narrative
Correction: updated the udi number in section d4.Additional information: initial reporter filed mdr number 1600580000-2024-8007 from their end.The device is expecting to be returned to our us facility, and will be forwarded to the manufacturing site for investigation once we have received it.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).
Additional Manufacturer Narrative
Correction / additional info: customer will not return the item to us for evaluation, thus we cannot ship it 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).
Additional Manufacturer Narrative
Additional information: no product was returned for investigation, but some photos of the product were received from the customer.It is visible in one of the photos that there is no rivet in the joint of the jaw part.It is therefore concluded that this is the piece of the instrument that broke and fell into the patients bladder.A likely scenario is that excessive force was applied to the joint (for example, by gripping non-intended material) on which the broken rivet was mounted.This causes excessive force to act on the joint, which can, for example, cause the rivet to shear off or the material in which the rivet was riveted to break.Another possibility is that the material of the bore in which the rivet is inserted has been expanded due to excessive force being applied.This event is filed under internal complaint id (b)(4).

• Brand Name: OPTICAL FORCEPS, FOR BIOPSY
• Common Device Name: OPTICAL FORCEPS, FOR BIOPSY
• 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 ; 4242188247
• MDR Report Key: 19563593
• Report Number: 9610617-2024-00175
• Device Sequence Number: 12656232
• Product Code: OCZ
• UDI-Device Identifier: 04048551079157
• UDI-Public: 04048551079157
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K950434
• 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,Followup,Followup
• Report Date (Section B): 01/21/2025

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: 27072A
• Device Catalogue Number: 27072A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 11/11/2024; 01/16/2025
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 10/29/2024; 12/03/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 91 KG