MAUDE Adverse Event Report: AESCULAP AG DISPOSABLE BIPOLAR METZ SCISSOR 5/310MM; HANDHELD PRODUCTS & LIGATION

Model Number	PL700
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a disposable bipolar metz scissor 5/310mm (part # pl700) was used during a laparoscopic cholecystectomy procedure on (b)(6) 2023.According to the complainant while using the scissors to cut down adhesions the device broke and fell inside the patient.The surgeon was able to retrieve the broken pieces.A delay of 10 minutes was reported.The adverse event is filed under aic reference (b)(4).
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: aesculap ag has carried out a visual and microscopic inspection; the product was manufactured in 04/2019.Aesculap ag carried out a test in function, and it was detected that in the adapter the ceramic insulation and the working end is broken, therefore the function is also not given.The canceled end of work was not made available for examination.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and the products found to be according to specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Conclusion/preventive measures: on the basis of the current information and as well as a result of the investigation, a definitive conclusion cannot be drawn.There is no indication for a material defect or manufacturing failure.The product is outside the warranty period.According to the ifu ta010096 2022-10 change no.Ae0062044, there are points given in order to prevent damage caused by improper setup or operation, general safety information, product specific safety information, and assembly guidelines.Also, not to compromise the manufacturer warranty and liability.

• Brand Name: DISPOSABLE BIPOLAR METZ SCISSOR 5/310MM
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 17956895
• Report Number: 2916714-2023-00098
• Device Sequence Number: 5033794
• Product Code: GEI
• UDI-Device Identifier: 04038653379651
• UDI-Public: 4038653379651
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024
• Report Date (Section F): 10/18/2023

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 Expiration Date: 04/07/2024
• Device Model Number: PL700
• Device Lot Number: 52511312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/26/2023
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 05/08/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/18/2023