MAUDE Adverse Event Report: AESCULAP AG SHUMACHER BIOPSY/RNGURLRG-TPSTR240MM; GENERAL SURGICAL INSTRUMENTS

Model Number	ER064R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
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 (b)(4) that a shumacher biopsy/rngurlrg-tpstr240mm (part # er064r) was used during a procedure performed on an unknown date.According to the complainant, one of the forceps' arms fractured while attempting to extract samples from the cervix.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 (b)(4).
Additional Manufacturer Narrative
Correction/additional information: b1 + b2: adverse event.B5: patient harm changed.H1: serious injury.H6: codes.Investigation results: visual investigation: the forceps is in a used condition, the driving pin of the movable handle is broken up and is remaining in the upper slider.Vigilance investigator carried out the pictorial documentation visually and microscopically.The driving pin of the handle is broken off.The analysis of the fracture pattern illustrated a forced fracture due to overload, e.G.During handling or reprocessing.No pores, inclusions or foreign bodies could be found on the point of rupture.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.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 upon the investigations results a capa is not necessary.
Event or Problem Description
Correction/additional information: patient harm changed to additional medical intervention.

• Brand Name: SHUMACHER BIOPSY/RNGURLRG-TPSTR240MM
• Common Device Name: GENERAL SURGICAL INSTRUMENTS
• 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: 12755836
• Report Number: 9610612-2021-00692
• Device Sequence Number: 19616451
• Product Code: HFB
• UDI-Device Identifier: 04038653154845
• UDI-Public: 4038653154845
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• 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): 01/27/2022

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: ER064R
• Device Catalogue Number: ER064R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 11/06/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown