MAUDE Adverse Event Report: AESCULAP AG MARYLAND DISP.GRASP.FCPS.BIPOLAR 5/310MM; HANDHELD PRODUCTS & LIGATION

Model Number	PL702SU
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a maryland disp.Grasp.Fcps.Bipolar 5/310mm (part # pl702su) was used during a procedure performed on (b)(6) 2021.According to the complainant, the base of the blade was broken while the customer was holding the handle and operating it.The issue occurred prior to gripping tissue.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
According to our final reporting evaluation, this event is considered no longer reportable for the following reason: product risk analysis (pra) was updated and severity was reduced to 2(5) from 4(5).Investigation: we made a visual inspection of the product.The instrument was forwarded to the manufacturing area for examination.Jaw section holder was severely bent.Axle pin on jaw broken off at weld seam.Function is no longer given.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level ((2)5 severity x (3)5 probability of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: the way the jaw section holder is broken, a massive lateral force must have been applied to the holder.Presumably the instrument was used for levering.No defect can be detected on the production side; most probably a user error.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based on the investigation results, a capa is not necessary.

• Brand Name: MARYLAND DISP.GRASP.FCPS.BIPOLAR 5/310MM
• Common Device Name: HANDHELD PRODUCTS & LIGATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12822215
• Report Number: 9610612-2021-00729
• Device Sequence Number: 12166253
• Product Code: GCJ
• UDI-Device Identifier: 04046963398811
• UDI-Public: 4046963398811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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 Expiration Date: 06/28/2026
• Device Model Number: PL702SU
• Device Catalogue Number: PL702SU
• Device Lot Number: 52689088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown